Quality Control Manager 1

Overview

Bio-Rad is seeking a Quality Control Manager I to lead the QC team for IVD product lines at our Seattle Operations site in Woodinville, WA. A typical day includes leading QC supervisors and teams across four QC groups supporting the BioPlex, EIA and IFA product lines, reviewing QC data and trends, aligning QC resources with the manufacturing schedule, and partnering cross-functionally through the material review board, CAPA and quality meetings. The role requires strong GMP knowledge and the application of risk-based processes.

How You'll Make An Impact: 

• Lead and develop a team of 15+ direct and indirect reports, including QC Supervisors, Technicians and Specialists, with plant-wide QC responsibility across multiple product lines. 
• 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 in collaboration 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.

What You Bring: 

• Education: Bachelor's degree or equivalent in a life science or related field. 
• Work Experience: 8+ years of quality control or manufacturing experience, including 5-8 years of supervisory experience. 
• Thorough understanding of ISO 13485, FDA regulations, 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, negotiation with a strong customer focus; 
• Familiarity with SAP or a similar ERP system AND Veeva or a similar QMS system are a plus.

Location: This position must be based in Woodinville, Washington and requires the employee to be located within commuting distance of the office.

Total Rewards Package: At Bio-Rad, we’re empowered by our purpose and recognize that our employees are as well. That’s why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio-Rad's robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle. 

Benefits: We’re proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds, a new fertility offering with stipend, group life and disability, paid parental leave, 401k plus profit sharing, an employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance, wellness challenges and support, paid time off, Employee Resource Groups (ERG’s), and more!

Compensation: The estimated annual salary for this position is $116,100 to $159,600 annually, at the time of posting.  Actual compensation will be provided in writing at the time of the offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. This position is eligible for a variable annual bonus, which is dependent upon the achievement of your individual objectives and Company performance. 

Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and health-care. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives.  Bio-Rad offers unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.  

EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all races, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply.

Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

Fraud Alert: Bio-Rad has received reports of individuals posing as Bio-Rad recruiters to obtain information, including personal and financial, from applicants. Beware of these fake "recruiters" and job scams. Click here for more information on this scam and how to avoid it. #LI-LL1