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
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
Biotech Quality Assurance
We are a company in toronto, received our federal govt. Licence from health canada as a commercial producer of medical cannabis under new mmpr regulations. We are looking for quality assurance person for our production facility. Full training will be provided in our state of the art laboratory.Please contact for discuss this further.
Thanks & best regards,
kuda . . . .+6 Other Responses
Testing And Quality Assurance Software
We are looking to speak with multiple experts based in na, uk, or germany that works on it/software development specific to testing and quality assurance.
We are interested to speak with someone that is part of a committee that evaluated the strengths and weaknesses of various solutions.
This is a paid 30-45 min phone consultation. Please provide a brief response below as to your relevance in the space.
1. Is your company’s annual revenue more than 1.5b?
2. Is your company investing in a digital transformation initiative?
+121 Other Responses
Clinical Quality Assurance
We're looking for a clinical quality assurance auditor:
1. Gcp or gxp auditing experience in a cro, pharma, or biotech setting.
2. The ability to travel
3. General knowledge of regulations: 21 crf part 11, gcp guidelines & standards.
-flexible work schedule.
-proven potential for professional growth.
-a community of brilliant minds at your disposal.
-the stability of working for a robust, financially sound cro that is growing at a sustainable pace.
-exposure to more than 20 therapeutic areas, including cutting edge therapies such as immuno-oncology, biosimilars, gene therapy, and new molecular entities.
As a clinical quality assurance auditor you will:
-assure that processes, quality systems, and inter-location synchronization within are aligned to promote an efficient working environment that follows compliance to regulations, standards, and good gcp guidance and provides clear pathways for inquiry, reporting, and resolution through audit, the capa process, and quality metrics.
-serve as liaison for quality compliance to all locations providing oversight from a corporate level.
-write and issue audit reports and communicate audit findings to relevant project team members and/or functional area management. Administrate the controlled documentation program by reviewing, revising, and writing sops.
-identify inefficient or outdated working procedures, develop revision plans, and conduct future review to determine the success of the procedure modifications.
-travel to multiple locations to conduct internal audits. Travel to suppliers to conduct vendor qualification and assessment audits.
-bachelors degree in a science or related field.
-at least 3 years of cro or pharma related experience.
-at least 2 years of relevant gcp auditing experience in a pharma, medical device, cro, or similar environment.
-general knowledge of relevant regulations including 21 crf part 11 and gcp guidelines and standards.
-asq-cqa or similar certification desired.+33 Other Responses
I am looking for an expert in quality assurance who also has specific domain knowledge in a particular industry vertical. The ideal consultant will have in depth knowledge of the big picture challenges facing a specific industry, plus the principles of quality assurance and how they relate to the industry.
My name is adam and i am the manager of marketing for dundas data visualization. We are conducting interviews with consultants as part of our research for marketing collateral, as well as a training exercise for sales people who are being assigned to deal with specific topics and industry verticals
my budget for a 1 hour consult is approx. $200, so replies that stay within that range will be favoured.
Thank you+34 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
Material Quality Assurance
We require an expert/consultant who can provide expert testimony in the icc (international chamber of commerce) regarding a potentially defective component used in the product developed by the client. The expertise is required in the following areas:
• industry standard(s)/benchmark(s) for quality testing of materials though the supply chain and manufacturing process;
• cross reference with iso 9001 standards for purchasing process in the engineering and, if possible, the mining industry.
• strong expertise in providing expert reports
• ability to attend hearings and have strong expertise in providing expert witness testimony
the scope of the project will be in the following countries: (expert can be located elsewhere)
• france, switzerland and spain
kindly let me know if you would be interested in this assignment and please attach your resume and your linkedin details (if any) as a part of this mail.
+34 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
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
Quality Assurance Manager - Clothing Manufacturing
responsible for the design and implementation of policies and procedures to ensure that quality standards are defined and met.
ensure that all quality standards are followed in order to ship only high-quality products from both purchase orders and distribution orders.
Education / knowledge / experience
• requires a bachelor’s degree and at least 6 years of experience in the field or related area.
• familiar with standard concepts, practices, and procedures for quality standards in the industry.
• relies on extensive experience and judgment to plan and accomplish goals.
• leads and directs the work of others within the quality function.
Responsibilities / duties (essential functions):
1. Oversee the inbound quality inspection process at the waverly, tn distribution center.
2. Work with charles kim on inspections in the factories.
3. Review in detail all ai audits and hold accountability before releasing shipments.
4. Work closely with the sourcing manager on all po’s and ensure everything is correct before releasing shipments.
5. Partner with the vp of global supply chain and address any and all quality issues with any and all upcoming po’s.
6. Partner with the design team and marketing to ensure all information we are sending our manufacturers is correct.
7. Compile and track data on poor quality issues, develop process improvements, and review with upper-level management.
8. Identify employees who negatively impact quality and work with them and their managers to ensure appropriate training is provided to eliminate the problems.
9. Implement an iso corrective action process for the po side of the business similar to the do side of the business.
10. Develop more efficient processes for gathering/reporting the quality inspection report information.
11. Facilitate manufacturer plant quality inspections when we have large quantity purchases or first-time production.
12. Work closely with the do side of the business to identify quality issues coming to the distribution center; propose changes to reduce those quality concerns.
+23 Other Responses