Medical Device Design Quality Engineer
Position: design quality engineer and manager
location: hudson, wi
qualifications - education & experience
bachelor degree in an engineering discipline or equivalent experience, per engineering criteria matrix
minimum six (6) years quality/regulatory experience
minimum three (3) years design engineering quality experienceteam-centric design experienceasq certification preferred
responsibilities
-manage acceptance of product and deliverables from the design process including dhf and engineering project file documents (protocols and reports).
-manage the design validation and process validation activities for the development program
-contribute to the design and development of components, assemblies and devices for various industries, including medical, defense and industrial
-take responsibility for the risk management process, including the subordinate activities and manage the comprehensive risk management file for the development program.
-participate on development teams representing quality
-provide engineering team with information and analysis tools as needed
-lead and coordinate quality system audits - both internal and external
-implement systems and procedures compliant with iso 13485
-coordinate new process techniques that improve overall job efficiencies
-participate actively in annual business planning efforts including establishing key performance measures, means of data collection, and reporting
-development and implementation of statistical incoming and in-process sampling/control plans
-manage the qualification of processes performed by company suppliers; troubleshoot and lead corrective actions relating to supplier performance; improve process for supplier data submission to reduce internal inspections
-implement systems and procedures compliant with iso 13485
-coordinate new process techniques that improve overall job efficiencies
-develop and manage qualified qa/qc team. Evaluate performance and recommend recognition and reward in accordance with established procedures
-responsible for being a communication liaison between the customer and manufacturing facility
-extended travel to other facilities may be required to support business needssome programs may have vision requirementsother duties as assigned
-provide leadership to the design quality team
-serve as the a mentor to the junior design quality engineers
-actively participate in the building of the design quality team
-represent the design quality team in new product introductions, and serve as the design control subject matter expert (sme) for the facility.
-complete performance evaluations and communicate performance standards and results with the worker
qualifications - skills & competencies
-understanding of design and development processes, associated terminology, and iso 9001-2000, iso 13485, and fda regulated product quality requirements.
-ability to effectively present information and respond to questions from managers, sales personnel, and customers
-strong communication (verbal and written), teamwork and organizational skills
-ability to identify problems, and develop and implement actions to resolve them
-ability to motivate and influence people to achieve compliance to requirements
-demonstrable track record of project accomplishment
-demonstrable track record of planning activities with contingency actions
+17 Other ResponsesCeo And Board Members For A Medical Device Company
Repost -- mdb is an authorized zintro partner.
Mdb is looking for a ceo and three board members for one of its new start-ups called electroblate, inc.
Can you help us fill these positions? If your referral for the ceo position is hired you will earn a reward of $20,000. If your referral for a board position is appointed you will earn $10,000. Note: you are welcome to apply for the positions, but are not eligible for a referral fee for referring yourself.
Here is how it works:
1. Submit the candidates (or apply) via the following links:
- ceo position: http://bit.Ly/1rxtd43
- board position(s): http://bit.Ly/1wrhraj
2. Within one week you will receive feedback and you will be kept up to date with the progress.
Here is a brief description of electroblate and you can learn more by clicking on the links provided above. Electroblate, inc. Is a clinical-stage, medical device company developing a unique platform to induce programmed cell death (apoptosis) in soft tissue non-thermally. By inducing apoptosis the body doesn't recognize injury and repairs the treated tissue with normal tissue in the treated area. The applicable worldwide market, exceeds $15 billion, and targets multiple therapeutic applications, such as tumor/cyst/unwanted tissue ablation, and multiple cosmetic applications.
The company is a technology ?Roll-up? Being created by mdb to acquire the operations and ip of three companies and two universities, enabling electroblate a dominant ip position in this technology area. In addition, the principal scientists and inventors are equity holders and will be working with the company to help further the technology platform.
Thanks again for your help in our mission of maximizing the probability of success of these disruptive technology companies!
best regards,
chris
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One of our clients is seeking to learn about the process of medical records retrieval in the p&c insurance industry.
If you work at a p&c insurer or have experience consulting for such an organization - are you familiar with the process of attorneys / litigators using third-party records retrieval firms to retrieve medical records for a p&c insurance case?
If so - we would love to discuss next steps.
+undefined Other ResponsesDefense Contract And Brokering
Good day,
i am looking for someone with experience in defense contracts and defense brokering to teach me and help me set up a defense contracting company in the us. Have some connections with some small arms manufacturers and aviation spare part businesses. Have also a network outside the us for garment manufacturing (knits & wovens). Please contact me if interested maybe a joint venture could come out of this. I am basically asking for guidance on how the system works and advice on what would be the best way to start. I am not a manufacturer. I am looking to broker or source & purchase as the core of my business.
+16 Other Responses
