Quality Engineer II

Quality Engineer II

Location: Salt Lake City, UT, United States

Position Type: Unfixed Term

Job Function: Quality

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A world leader in the field of in vitro diagnostics for more than 60 years, bioMerieux 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:

Ensures, through global and local Product Development Process procedures and efforts, that Molecular products are developed, tested and transferred to manufacturing according to established procedures that will assure that they meet all quality requirements. Responsible for the implementation and maintenance of effective Quality Systems in accordance with FDA Quality Systems Regulation, ISO 9001, ISO 13485 and other applicable country specific regulations. Participates and provides guidance to quality improvement teams on tools, techniques and management systems for quality assurance, compliance, and continuous quality improvement. Primary Duties:

• 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

Training and Education:

• Required- Bachelor's Degree in science or engineering discipline. Master's degree in a scientific discipline is preferred, minimum (5) years of relevant Health Industry (IVD, MD, Biotech or Pharma) experience within R&D, Product Development, Design Controls, Technical support, QE/QA/QC or Regulatory Affairs required.
• Knowledge in biology, and specially in molecular biology is preferred, but not required.
• Must have exposure to and knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (ISO 13485, 21CFR820, EN 62366, IEC 62304, ISO14971, 21CFR11, MDR 2017/746 and CLSI)
• Requires effective written and oral communication skills to interact across all levels of the organization.
• Must have experience in and knowledge of Microsoft Office Package (Word, Excel, etc.).
• One or more of the following certifications is desired for this role: Certified Quality Engineering (CQE), Certified Quality Auditor (CQA), Certified Software Quality Engineer (CSQE), Certified Reliability Engineering (CRE), Certified Biomedical Auditor (BCA), or Six Sigma Black Belt.
• In lieu of degree and type: +5 Years In Quality Control or Quality Assurance

Experience:

• Minimum 5-years previous on-the-job experience requiring professional communication and interactions utilizing skills outlined below
• Previous experience in anEngineering, Scientific or Investigative role is required.
• Demonstrated competence in the selection and use of Quality Engineering tools, techniques, and processes is preferred.
• Experience in Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system with involvement in Design controls is preferred.
• Experience and/or education in biology, and specifically in molecular biology is preferred, but not required.
• Master's degree in relevant discipline is highly desired.

Knowledge, Skills, Abilities:

• 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

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMerieux 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 recruitment@biomerieux.com.

BioMerieux 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 BioMerieux's or its affiliates' application process by contacting us via telephone at (385) 770-1132, by email at recruitment@biomerieux.com, or by dialing 711 for access to Telecommunications Relay Services (TRS).

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