Quality Control Mgr I
About The Position
Bio-Rad is seeking a Quality Control Manager I to lead the QC team for IVD product lines at its Seattle Operations site in Woodinville, Washington. The role has plant-wide QC responsibility across multiple product lines and four QC groups supporting BioPlex, EIA, and IFA. The manager leads QC supervisors and teams, reviews quality data and trends, aligns QC resources with the manufacturing schedule, and partners with other functions through material review, CAPA, and quality meetings. Strong GMP knowledge and the application of risk-based processes are required. The manager develops a team of 15 or more direct and indirect reports, manages the QC budget and improvement strategy, and drives the completion of quality issues. The role also oversees environmental monitoring, reviews validation protocols against Division requirements, and leads continuous-improvement projects. The position must be based within commuting distance of the Woodinville, Washington office.
Requirements
- Bachelor's degree or equivalent in a life science or related field.
- At least 8 years of quality control or manufacturing experience.
- 5–8 years of supervisory experience.
- Thorough understanding of ISO 13485, FDA regulations, and GMP and GLP requirements.
- Excellent technical and analytical skills, with the ability to resolve problems of diverse scope and complexity.
- Strong communication, public-speaking, decision-making, and negotiation skills, with a strong customer focus.
- Must be based within commuting distance of the Woodinville, Washington office.
Nice To Haves
- Familiarity with SAP or a similar ERP system.
- Familiarity with Veeva or a similar QMS system.
Responsibilities
- Lead and develop a team of 15 or more direct and indirect reports, including QC Supervisors, Technicians, and Specialists, with plant-wide responsibility across multiple product lines.
- Review QC data and trends and align QC resources with the manufacturing schedule.
- Monitor Quality Notifications (QNs), Nonconformance Reports (NCRs), and CAPAs and drive them to completion.
- Analyze the daily back order report and resolve QC-related issues.
- Create and manage the QC department budget, implement QC cost-reduction programs, and develop the QC improvement strategy with site management peers.
- Present QC data at the monthly Cross-Functional Quality Meeting and define reporting criteria for KMI reports.
- Ensure environmental monitoring programs are effective and compliant.
- Review validation protocols against Division requirements and drive continuous improvement through special projects.
- Partner cross-functionally through the material review board, CAPA, and quality meetings.
Benefits
- Competitive medical plans for employees and their families
- Free HSA funds
- Fertility offering with stipend
- Group life and disability coverage
- Paid parental leave
- 401(k) plus profit sharing
- Employee stock purchase program
- Mental health platform
- Learning and development opportunities
- Education benefits
- Student debt relief program
- Pet insurance
- Wellness challenges and support
- Paid time off
- Employee Resource Groups (ERGs)
- Variable annual bonus dependent on individual objectives and company performance
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What This Job Offers
Job Type
Full-time
Career Level
Manager
