QA Manager Product/Process Risk

Biomerieux Saint Louis , MO 63150

Posted 2 months ago

A strong Scientific and technological pioneering spirit drives bio

Mrieux development since its creation in 1963. We design innovative in vitro diagnostic solutions for our customers that initiate new forms of scientific partnerships to be at the forefront of the most advanced technologies. Our presence in more than 150 countries with 9,400 employees worldwide secures bio

Mrieux commitment to public health.

bio

Mrieux products are used to diagnose infectious diseases, they provide high medical value results for cancer screening and monitoring, cardiovascular emergencies and contamination to improve patient health and ensure consumer safety. Products also include industrial microbiological controls to detect microorganisms in food, pharmaceutical and cosmetic products.

We are committed to creating an optimal work environment that fosters teamwork, emphasizes training and offers international career development opportunities.

QA Manager Product / Process

POSITION SUMMARY

This position will manage the risk management program at the site for both product and manufacturing process risk assessments post commercial launch, interacting across all levels of the organization. Responsible for defining/improving, implementing and maintaining risk management activities post commercial launch in compliance with ISO 14971. In addition, will ensure through both action and review that risk assessments are updated from sources of post market data including but not limited to complaints, post market surveillance data and other quality management systems. This position will be accountable to ensure Program Management and Operations Management assesses product risk timely, appropriately and ensure risks are documented and mitigated.

  • Maintains the RMF's for commercialized product as part of the Post-Market surveillance process in accordance with ISO 14971:2012

  • Acts as lead in implementing improvements to the STL post launch risk management program.

  • Accountable to ensure Program Management assesses product risk timely, appropriately, is

documented and mitigated.

  • Accountable to ensure Operations Management assesses process risk timely, appropriately, is

documented and mitigated.

  • Conducts risk assessments and revises risk management documents as required by Standard

Operating Procedures, FDA, EU and other medical device and IVD regulations in support of change control and complaints data.

  • Works with design engineers and R&D to support the change management process, identifying

and/or modifying risks, driving design mitigations and evaluating effectiveness of the risk control

measures.

  • Leads periodic and event driven risk reviews of the RMF's for commercialized products.

  • Support the complaints intake teams with assessment of risks related to reported complaints.

  • Support the change management process and manufacturing Quality with assessment of risks,

initiate and complete updates to risk analyses as needed.

  • Provide guidance to other associates on the application of appropriate risk management practices. Work closely with associates in product development, production, quality engineering, regulatory affairs, quality systems, and post-market surveillance as needed.

  • Establish appropriate practices for assessing risk resulting from manufacturing activities. Support preparation of process/equipment failure mode effect analysis (FMEA) documents.

  • Implement practices to update risk management documents throughout the product life cycle. Establish practices/procedures for revising top-down and bottom up risk as appropriate when new information affecting product risk is available. updates shall include; a) incorporating production quality data into pFMEAs on a continual basis (bottom up); and b) incorporating customer experience and field data into appropriate risk documents (top down and bottom up).

  • Support risk management practices and applicable documentation during internal audits and third-party inspections.

  • Performs additional responsibilities as assigned.

KNOWLEDGE, EXPERIENCE & SKILLS

  • Bachelor's or Master's Degree in Engineering, preferred Mechanical, Electrical, or BioMed

  • 10 years relevant experience in risk management / R&D / manufacturing for medical devices or the regulated industry with 3 or more years of experience with Medical Device Reporting requirements, preferably for the European Union.

  • Must possess a solid understanding of the potential sources of risk and how to manage risk in a manufacturing environment and based on post commercial data

  • Requires broad technical knowledge in manufacturing concepts, mechanics, electronics, software and/or systems engineering, including 3-5 years hands-on experience in direct manufacturing or direct manufacturing support.

  • Also requires experience working with complaints intake and complaints investigation teams.

  • Must have 6 or more years' experience with risk management per ISO 14971 (System Risk Analysis, Use Risk Analysis, dFMEA/pFMEA and other Risk Management tools), and proficiency with risk management tools, including FMEA, FTA and FMECA.

  • Must possess knowledge of usability or human factors engineering for medical devices

  • Must possess knowledge of medical device GMPs as defined by the FDA, EU and other regulatory authorities.

  • Must be skilled in collaborating with multi-disciplinary teams, and converse technically with people of varying backgrounds; be a master problem solver / decision maker; strategic thinker.

bio

Mrieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity.


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QA Manager Product/Process Risk

Biomerieux