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Mgr R&D Quality, Product Development

Location: Saint Louis, United States
Position Type: Unfixed Term
Job Function: Bioscience R&D

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

Position Summary:

Reporting to Pre-Market Quality, you will be in charge of Microbiology Products developed and supported in the United States. You and your team will be responsible for ensuring that the design is well controlled and that quality requirements are met in accordance with bioMérieux and international standards.

 

In this context, your main missions are

- Manage the team of R&D Quality Engineers involved in microbiology development projects

- Manage the interfaces with the R&D programs: define the budget, allocate resources to R&D projects

- As an expert in design control and product risk management, provide coaching as needed to project team members and infuse quality.

- Support internal / external audits or be lead auditor for strategic audits related to design and development

- Ensure compliance of R&D projects with recognized regulations and standards while proposing solutions that satisfy the business

- Contribute to functional excellence on design control or risk management by driving practice improvements and participating in global Pre-Market Quality initiatives.

- Implement Quality Engineering functional excellence (methods and tools) during product life cycle improving the quality and robustness of products partnering with Process Office

 

And below specificities for Support activities


- Provide coaching to Product Support Team as needed to ensure compliance to applicable regulations.
- Ensures the compliance and update of DHF documents and risk management all along the product/system life cycle.
- Ensure the monitoring of level 3 investigations resulting from customer complaints
- Accountable for key deliverables of design control (reports, traceability, impacts of changes)
- Accountable for key decision affecting the quality of product (anomalies, non-conformities, (complaints)

 

- Ensure there are relevant justifications for any conclusions on performances, safety, statement on deviation (auditability, statistical / scientific rationale)
- Contribute to CAPA, to root cause analysis, and subsequent critical decision taken (FCA or FSCA),to Change Review Board and follow-up
- Contribute to the reporting of Post-Market Surveillance Report

 

 

Required Skills/Qualifications

Bachelor's Degree with 8+ years of experience in systems/software and/or reagent development in the IVD or medical device industry. You are able to work in project mode and have excellent knowledge of Quality Management Systems. You have the ability to act as a quality auditor and are familiar with applicable standards (ISO 9001, ISO 13485, QSR-21 CFR 820, EN 62366, IEC 62304, ISO14971).

2+ years of supervisory experience 

 

This position requires direct management skills as well as leadership.

With excellent interpersonal skills and the ability to synthesize information, you will be able to promote simple solutions that meet business and compliance needs. You will be the bearer of this mindset in your team. Fluent English is essential for this position.

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [email protected].

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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