Quality Engineer III, R&D
This job posting is no longer active.
Location: Salt Lake City, UT, United States
Position Type: Unfixed Term
Job Function: Quality
A world leader in the field of in vitro diagnostics for more than 60 years, bioMérieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety.
In North America we have more than 6,200 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada.
Come and join a family-owned global company with a long-term vision, and a human-centered culture.
Description
Position Summary
- Perform all work in compliance with company quality procedures and standards.
- Quality Engineering Support for the Molecular R&D Design Control Process – Design, approve, and implement development effort/project planning as needed, review and approve project documentation as requested.
- Represent the Quality R&D function by participating in design reviews, developing quality engineering deliverables and assuring Design History File (DHF) is updated and reviewed for accuracy/ completeness when necessary.
- Provide guidance / support to program directors, project managers, product development teams, R&D, and Product Validation functions regarding application of design controls, scalability, and related development process practices and improvements.
- Contribute to the documentation of quality systems and programs in the area of training, change management, design control, including product verification and validation, CAPA for relevant design issues, documentation control considerations, etc. to ensure compliance with FDA and regulatory requirements.
- Develop and execute design control training programs (e.g. design change control, risk analysis, etc. as requested).
- Prepare for and support regulatory and agency inspections/audits (FDA/ISO/MDSAP/etc.), investigations, and inquiries regarding the control and assessment of product design quality. Support corporate/internal design control audits.
- Participate in site R&D CAPA activities and non-conformities/deviations including investigation, effectiveness, and root cause analysis, etc. Coordinate implementation of corrective actions and preventive measures, as needed.
- Function as QA subject matter expert for cross-functional development team related practices: facilitate risk management activities, provide guidance for strategy and content of requirements and specifications. Provide strategies and approvals for verification methodologies, configuration management, validation, and regression testing approaches.
- Ensure the maintenance of the Risk Management File of the products in your portfolio
- Competent understanding of Design controls
- Technical writing skills
- Writing procedures, flowcharting
- Ability to collaborate cross-functionally
- Application of Quality Risk Management principles
- Attention to detail (e.g. document reviews, design reviews).
- High level of written and verbal communications skills
- Ability to communicate with R&D Engineering and perform risk analysis as instructed.
- Wisdom to seek help when needed.
- Proficiency in MS Office tools, including Outlook, Word, and Excel
- Ability to remain in stationary position, often standing, for prolonged periods.
- Ability to ascend/descend stairs, ladders, ramps, and the like.
- Ability to wear PPE correctly most of the day.
- Ability to operate heavy machinery.
- Ability to adjust or move objects up to 50 pounds in all directions.
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).
