Job title: quality assurance manager - manufacturing
location: west chester, pennsylvania
reports to: president
competitive salary and benefits. Relocation offered for the right candidate.
The quality assurance manager is responsible for the development and implementation of the systems that ensure that our products and processes are meeting their goals for quality and improvement, in accordance with the quality policy and iso – certified quality management system, (qms). In order to achieve these strategic goals, the qa manager will lead a team of quality assurance roving inspectors and final inspectors as well as serve as the management representative for the iso 13485 qms. The qa manager will also communicate with customers on quality and other issues to ensure that effective steps are taken to measure and improve customer satisfaction, and serve as principal contact for quality audits, surveys, and corrective actions.
this position requires strict confidentiality. Access to company information will not be discussed with anyone inside or outside the company.
- work with management to develop specific and measurable goals, improvements and standards to continuously and consistently improve quality and reduce errors.
- act on behalf of the customer to audit and maintain the accuracy and timely delivery of products.
- ensure that first article inspections, (fai’s), are performed in a timely manner throughout the day.
- make sure that roving inspections are done at all work stations on a routine daily basis and results are reported back to the machinist.
- see to it that final inspections are done in a thorough manner and in accordance with shipping requirements and scheduling.
- maintain iso 9001 and 13485 medical device quality management system certifications and compliance.
Additional details of job description available upon request.
- bs engineering or related discipline, or asq certification, or equivalent experience.
- 10+ quality experience in a precision machining environment.
- experience with implementing and maintaining iso 9000 certification.
- knowledge of statistical process control practices.
- willing to work 40 or more hours weekly.
- basic computer knowledge. Familiarity with ms word, excel and outlook.
- cnc / swiss experience
please note: we are seeking to hire a full-time employee and are not interested in responses from those only interested in consulting.+75 Other Responses
Quality Management Software
Our us firm wishes to speak with head of quality / director of quality / vp of quality at f1000 companies to get their perspectives on their quality management (eqms) platform.
Companies that are in industries related to manufacturing use eqms to track the quality of their product as it is built / along the supply chain. Experts should be familiar with some / all of the following:
please rank on scale of 1-5 how familiar you are with each of these companies. Thank you.+33 Other Responses
Medical Device Quality Assurance
This full-time job post has been authorized by zintro.
We are seeking a quality assurance manager who is hands on and has experience with precision machine parts and machining. The quality assurance manager is responsible for the development and implementation of the systems that ensure that company products and processes are meeting their goals for quality and improvement, in accordance with the quality policy and iso – certified quality management system, (qms). In order to achieve these strategic goals, the qa manager will lead a team of quality assurance roving inspectors and final inspectors as well as serve as the management representative for the iso 13485 qms. The qa manager will also communicate with customers on quality and other issues to ensure that effective steps are taken to measure and improve customer satisfaction, and serve as principal contact for quality audits, surveys, and corrective actions.
This opportunity could go to director level.
Additional details of job description available upon request.
• bs engineering or related discipline, or asq certification, or equivalent experience.
• ten years quality experience in a precision machining (metal) environment.
• experience with implementing and maintaining iso 9001 and 13485 certifications.
• knowledge of statistical process control practices.
• extremely intuitive with problem solving and resolutions.
• excellent attention to detail and ability to multi task.
• able to work with minimal supervision, both alone and in teams.
• basic computer knowledge. Familiarity with ms word, excel and outlook.
• cnc / swiss experience.
• leadership experience.
• relevant experience in the medical device industry.
• special certification.
Competitive salary and benefits. Relocation provided.
Please note: we are seeking to hire a full-time employee and are not interested in responses from those only interested in consulting.
This position is not eligible for visa sponsorship.+14 Other Responses
Quality Assurance Development In California
This is a sr. Director of quality assurance,development full time position opportunity in california.
this position will have oversight and leadership of developmental quality assurance programs to meet phase appropriate compliance, validation, and gxp quality assurance requirements.
-establish and maintain a robust quality program that will effectively support the various phases of drug development – preclinical through phase 3, plus product/process improvements.
-employ the principles of ich q8 (pharmaceutical development) and q9 (risk management) to the development of manufacturing processes.
-ensure a systematic approach to development is employed that begins with pre-defined objectives and emphasizes product and process understanding and process control based on sound science and quality risk management.
-provide leadership and managerial oversight to the quality department responsible for development qa.
-establish and maintain a phase appropriate approach to product/process development qa.
-as project team member, represent qa on product development teams including pre-clinical, phase 1, 2, and 3 development studies, and manufacturing improvement teams.
-responsible for document review and qa release of ds/dp to be used in phase 1, 2, and 3 clinical studies.
-responsible for phase appropriate quality systems implementation for ds/dp manufactured for use in phase 1, 2, and 3 clinical studies.
-acts as technical advisor to vp global quality on topics related to development and commercial quality.
-develop and implement effective development qa programs aligned with corporate strategic initiatives and business goals.
-interpret regulatory authority regulations, guidelines and policies. Utilize internal audits and quality compliance assessments programs to evaluate processes and procedures as they pertain to product development activities.
-must be able to maintain a “big picture” perspective without losing site of the details necessary to meet deliverables and deadlines.
-supervise and develop quality personnel.
-direct the review and approval of the applicable sops, batch records, test methods, raw material specifications.
-provide quality expertise as needed for deviations reports and out-of-specification reports.
-ensure that manufacturing processes, equipment, facilities meet phase appropriate gmp requirements.
-ensure that suppliers and contract manufacturers associated with product/process development are operating in compliance with state, federal, and international gxp regulations and guidelines as necessary through an external audit program.
-hire and/or develop the team to establish and maintain efficient and effective quality systems and programs as they relate to product/process development.
-develop operational budgets, cost controls, cost estimates, capacity and resource plans to support corporate strategic business objectives.
-ba/bs in a relevant scientific discipline and a minimum of 15 years industry experience with 7+ years of management experience providing both strategic and leadership guidance to an organization in quality assurance. For senior director level consideration, the ideal candidate must have at least 2 years’ experience at the director level.
-must have a development quality background from the biotechnology/pharmaceutical industry.
-experience in quality management and compliance systems.
-in-depth knowledge development qa and experience implementing phase appropriate quality systems to achieve gxp compliance.
Contact us here on zintro for further details.+13 Other Responses
Laboratory Quality Assurance In Uae
Job title: qa director
this job post has been authorized by zintro.
- this is a responsible, professional, supervisory, and technical position in the administration of a specific department of the medical laboratory.
- the quality assurance director plans and directs the quality management system programs and practices of the lab to ensure patient safety, compliance with all local and international accreditation standards, and scientific best practices.
- the director works closely with all members and levels of the our team to ensure compliance with the aforementioned. Responsibilities are performed with considerable independence with accountability to the medical director and the chief executive officer.
**key job summary**:
- ensure the overall quality of services rendered to laboratory clients relative to reliability, accuracy, and precision.
- provide proactive leadership in the identification and rapid resolution of problem issues which adversely affect quality
- direct quality programs including the implementation of policies and systems which lead to continuous quality improvement.
- promote a culture of quality throughout the laboratory system through communication and increased quality awareness.
- direct the daily operations of the qa/qc department.
- maintain standard performance of laboratory staff and technical operations to ensure accurate and consistent testing procedures.
- train, mentor, and evaluate laboratory staff to ensure quality control, safety, and record maintenance, in coordination with technical leadership.
- ensure every laboratory is inspection-ready.
** preferred experience**:
- communicate qa programs to technical and administrative staff.
- establish standard operating procedures and safety standards
- knowledge of cap / jci / iso 15189 accreditation requirements
- international certification on quality management (preferred)
- american society of clinical pathologists (ascp) certified iso 15189 experience.
- work autonomously
**minimum qualifications and experience**:
- bsc in medical technology with appropriate clinical internship/ laboratory technology or biomedical science
- minimum of seven (7) years as a quality assurance manager/director in a college of american pathologists accredited laboratory.+3 Other Responses
We are a small company that manufactures electrical safety equipment. In addition to our products, we brand label for schneider electric. Their customers are a lot of hospitals that use 10-25kva transformers - these are mounted in steel back boxes. Unfortunately these back boxes have been coming to us with bad welds and they are not staying together. These transformers as you know are very heavy and this has become a safety concern. Since we are a small business we would like to have an experienced quality assurance associate inspect these boxes and give their opinion to schneider.+7 Other Responses
Quality Assurance Service
this is mafas we have an immediate opening with one of our client. Kindly confirm your interest by replying to this email with your updated resume and convenient time/number to discuss further.
In case if you are not currently available or not interested in the below position, i apologize for the inconvenience and request you to forward my mail to your friends or colleagues whom you feel would excel this opportunity
job title: qa- quality assurance
location: pleasanton, ca
terms: contract to hire
summary of experience :
· good experience in a linux and db2 (or similar sql) environment.
· automation tool soap ui, java not required but a plus.
· any deployment with anthil or jenkins a plus.
· experience with transaction processing, particularly financial – also a plus
thanks & regards
mafas+5 Other Responses
A quality assurance, quality services, processes, iso 9000 compliance expert or consultants company in the miami fl. Area+10 Other Responses
Vice President Quality
Vice president of quality: this is a full-time employment opportunity onsite in seattle washington, usa.
Responsible for oversight of the quality assurance (qa), quality control (qc), and validation departments. The vp works closely with the leadership team to develop and execute the corporate goals and objectives for the company. The position is responsible for leading the company as a clinical and commercial manufacturing organization. The vp is responsible for oversight of the site quality systems and assuring the overall gmp compliance with current regulatory requirements and guidelines.
-15+ years of experience in biotech and/or pharmaceutical manufacturing
-10+ years of experience in quality operations (qa, qc and/or validation) within biotech and/or pharmaceutical industry
-exceptional customer interface skills are required
-strong working knowledge of quality systems (fda qsit and ich q10) and how those systems are implemented to meet fda and ema requirements
-experience supporting regulatory filings (e.G., inds, blas, mms, etc) and leading product-related inspections for us and foreign regulatory agencies
-experience developing, implementing and executing strategic plans and objectives for organizations and departments.
-provide leadership and direction to the quality organization.
-serve as an active member of the site leadership team responsible for development and setting of site strategy and goals
-mentor and develop staff members within the organization.
-the vp of quality holds final accountability for and decision making on the matters relating to gmp compliance for the site.
-responsible for setting the overall strategies and directions of the qa, qc and validation departments. Decisions are focused on key strategic and operational matters that have significant, direction-setting impact on the overall company.
-responsible for setting and aligning goals and objectives for the qa, qc and validation departments with the overall corporate goals and objectives. Ensuring that the goals and objectives are accomplished. Failure to effectively execute responsibilities may negatively impact critical, company-wide goals, objectives, and outcomes. In addition, there may be legal and regulatory consequences.
-accountable for development of qa, qc and validation departmental budgets that support the corporate and departmental goals and objectives. Responsible for controlling the budget during the fiscal year.
-provides advice and counsel to the leadership team on regulatory gmp compliance issues.
-serves as the principal site spokesman with customers, regulatory agencies, etc., on matters of regulatory gmp compliance.
-requires the ability to negotiate and achieve alignment with executive management and external audiences at the highest levels, including regulatory agencies.
-works with other sites to align and integrate quality systems.
Please contact us here on zintro to learn more.+58 Other Responses
Lab Qa/qc Management
Looking for experienced qa/qc managers in laboratory setting to help understand calibration of liquid equipment handling (handheld pipettes and automated systems)+9 Other Responses
Commercial Quality Assurance In California
This is a full time opportunity in california: sr. Director, quality assurance - commercial
this position will have oversight and leadership of the commercial quality and quality systems teams and be responsible to meet compliance and quality assurance requirements for commercial pharmaceutical manufacturing.
-effectively employ the principles of ich q9 (risk management) and ich q10 (pharmaceutical quality system)
-develop and lead a risk based quality management system.
-build and maintain robust quality program that will effectively support commercial manufacturing.
-provide leadership and managerial oversight to the quality departments responsible for quality systems and commercial quality.
-administer commercial quality systems including:
-quality management review
-annual product review
quality oversight of contract manufacturing organizations including:
-batch record review
provide support as necessary to the vp global quality regarding gmp readiness, quality related projects and issues/concerns on a global basis.
-conduct ongoing evaluations of quality programs, systems and initiatives to assure that product quality standards and regulatory compliance are achieved.
-interpret regulatory authority regulations, guidelines and policies. Utilize internal audits and quality compliance assessments programs to evaluate dynavax processes and procedures.
-conduct regular risk assessments to ensure processes and procedures are in compliance with cgmps.
-supervise and develop quality personnel including the heads of applicable functional teams.
Appropriately resource regulatory inspections.
-direct the review and approval of the quality manual, quality policies, protocols, sops, batch records, test methods, raw material specifications, and annual product reviews.
-provide quality expertise as needed for deviations reports and out-of-specification reports.
-ensure that manufacturing processes, equipment, facilities and systems are validated and that a robust change control system and procedures are developed and maintained to meet state, federal, and international requirements.
-ensure that suppliers and contract manufacturers are operating in compliance with state, federal, and international gxp regulations and guidelines through an external audit program.
-hire and/or develop the team to establish and maintain efficient and effective quality systems and programs.
-develop operational budgets, cost controls, cost estimates, capacity and resource plans as well as facility requirements to support corporate strategic business objectives..
-ba/bs in a relevant scientific discipline and a minimum of 15 years industry experience with 7+ years of management experience providing both strategic and leadership guidance to an organization in quality assurance. For senior director level consideration, must have at least 2 years’ experience at the director level.
-must have a quality background from the biotechnology/pharmaceutical industry with gmp experience and a successful track record in quality within fda and/or emea regulated environment.
-experience in quality management and compliance systems.
-in-depth knowledge of qa document control, gxp compliance, and qa auditing.
-experience in development qa associated with pre-clinical development and commercial products. --a background in the development of analytical methods preferred.
-must have a successful track record in managing fda/eu inspections.
Contact us here on zintro for further details.+11 Other Responses
Quality Control Director
Oversee day to day operations of the quality control, document management, raw materials and stability groups. Works closely with managers to ensure testing operations are performed, including capacity management, metrics and execution of testing. Maintains rigorous quality mindset and advocates strict adherence to compliance practices within the testing labs and facility. Possess scientific skills in the specific science area and a strong working knowledge of the technical, usp compendial testing, and current good manufacturing practice (cgmp) compliance requirements for in-process, raw materials and product quality testing. Remains current regarding product quality testing needs for biosimilars and works with the technical teams to develop / modify assays to meet requirements. Ensures that appropriate records are maintained according to and in compliance with fda guidelines for biosimilars, usp, glp, cgmp, code of federal regulations (cfr) and/or points to consider (ptc) guidelines, ich guidelines, and sops. Works closely with the analytical research and development team to receive and validation of new assays and technologies, as well as existing assays. responsibilities:
ensures quality control testing is scheduled and performed develops and manages to operational and performance metrics supervises, plans and reviews operations for assigned staff, including responsibility for training, managing and evaluating as well as coordinating, scheduling and assigning work and maintaining standards recommends hire / transfer / promotion / discharge and salary changes and acts on employee problems conducts employee performance appraisals in a timely and objective manner may act as study director for assigned assays and assumes all associated responsibilities interacts with other functional groups to discuss project planning and testing issues works with the analytical research and development team to provide strong in-house guidance on science and technology interacts with internal staff to identify assays requiring further improvement or development responsible for appropriately conducting assays in accordance with cgmps assures that laboratory personnel are following all company sops and safety rules prepares and revises technical documents (laboratory protocols, change controls, oos investigations, capas, sops, etc.) assures that test batch records and deviations, oos results, qa audits and other paperwork are completed according to cgmps and company sops
ph.D. In biochemistry/analytical chemistry with 10 years or bs or ms with 15 years quality control industry experience must have 8 or more years of experience with proteins and antibodies knowledge of cgmp and biosimilars guidelines is desirable ability to make decisions based on a wide knowledge of factors where application of advanced or technical concepts is predominantly required ability to evaluate technical data and write technical documents ability to use judgment as dictated by complexity of situation ability to work under limited supervision and to handle problems of a difficult nature ability to accomplish the described duties through the use of appropriate laboratory equipment (i.E. Biohazard hood, centrifuge, incubator, and autoclave) and computer equipment and software. (i.E. Microsoft word, outlook) +40 Other Responses