Would you like to join an innovative team creating technology to power groundbreaking insights in academic, clinical, pharma and biotech research?
Our life science analytical and preparatory systems in mass cytometry and genomics can be found in leading academic institutions, clinical research laboratories, and pharmaceutical, biotech and ag-bio companies worldwide. Our mission is bold and ambitious, powering advancements in human health research that can change lives.
Fluidigm is looking for a well-rounded and knowledgeable Sr. Quality Engineer to join our Quality Assurance team.
- Experience in risk evaluation techniques, e.g. Risk Assessment, dFMEA, pFMEA, fault tree analysis, etc.
- Coordinate the risk management program and chair cross-functional teams to develop product risk management files.
- Draft risk management plans, perform product risk assessments, facilitate FMEA, and create a final risk management reports.
- Ensure that product development projects and changes to existing products are conducted in compliance with design control, change control and regulatory requirements.
- Serve as a Quality Core Team member on new product development and sustaining engineering project teams.
- Assist in the review and approval of verification and validation test plans and reports.
- Coordinate the change control program, ensuring change requests are reviewed, circulated for approval, and tracked through all phases of change implementation and effectiveness verification.
- Provide training to project teams on procedures, risk management, design controls and change controls.
- Review Design History Files and Technical Files for conformance to applicable requirements.
- Review new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
- Assist with internal, external and third-party audits, as necessary.
- Provide QA support to facilitate the rapid resolution of product complaints and/or safety issues, especially as related to risk management activities.
- Ensure Risk Management is effective utilizing feedback from validation, post market surveillance, manufacturing indicators, NCRs, CAPAs, etc.
- Support the QA/RA department with generation of technical files, as necessary.
- Technical Degree (BS or higher) in a biological or chemical engineering discipline and 8+ years of experience working within/developing Quality Systems in compliance with ISO 13485, US and European regulations/standards.
- Prior experience managing/overseeing risk management (ISO 14971) and change control required.
- Strong familiarity with regulatory requirements (e.g. ISO 13485, 21 CFR 820 & ISO 14971)
- Familiarity with European requirements (such as RoHS 2011/65/EU, Low Voltage Directive 2014/35/EU, Electromagnetic Compatibility 2014/30/EU) a distinct advantage.
- ASQ CQE, CRE, CSQE certification desirable, but not essential.
- Recent (within two years) hands-on auditing experience (internal, external, third-party).
- The ability to work across the organization with all levels of employees to ensure that the value of the quality program is understood and embraced.
- ISO 13485:2016 lead auditor certification a plus.
- Familiarity with the Medical Device Directive (or Regulation) and In Vitro Diagnostic Directive (or Regulation) preferred.
- Experience with in vitro diagnostic medical device product preferred.
Sounds good? Apply online with your resume!
Fluidigm is an equal opportunity/affirmative action employer. We will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, age, or national origin.