BioTalent is hiring a Quality Assurance Manager for a leading global clinical diagnostics and research instrumentation company in Seattle, WA.
Position Requirements:
- Supervises and leads staff responsible for Quality Management System oversight. This includes management and development of staff, communication of organizational and departmental goals, coaching and annual performance assessments.
- Reviews product batch files and conducts final product release.
- Controls materials per the applicable QMS procedures for ship holds, quality notifications, complaints, CAPA, Validation, Risk Management.
- Escalates issues appropriately to Regulatory Affairs to assess Regulatory Requirements.
- Leads, advises and works cooperatively with various departments to support production of products distributed by Seattle Operations. This activity includes but is not limited to management of Changes, CAPA, Validation, NC and Risk Management.
- Facilitates the preparation for quarterly Management Review.
- Participates in external audits, completes responses as assigned on time.
- Manages the Learning Management System and GMP training program including development of learning plans and conducting GMP training.
- Prepares local standard operating procedures.
- Leads and supports Quality Objectives as assigned.
Requirements summary:
- B.S. or Advanced Degree
- 2-3 years minimum supervisory/managerial experience
- 5+ years of experience within a regulated medical device or diagnostics space
- Preferred Expertise: quality assurance, change control, document control, GMP training, validation
- Familiar with ISO 13485 and 21CFR820