Quality Control Spec I

Overview

You are responsible for driving the resolution for product quality issues through collaboration with production, manufacturing engineering and supplier quality teams. You would monitor process data and initiate improvements to meet organization objectives, ISO 13485 (MDSAP) and applicable regulatory requirements. You will also support QC Instrument Test on reagent management and procedural update to meet delivery commitment. 

How You’ll Make an Impact:

• Initiate internal and/or supplier non-conformances review meetings to ensure timely disposition and closure of QNs.
• Proactively monitor QC test yield, collaborate with Engineering and Manufacturing to identify and implement improvements to manufacturing processes or QC test procedures.
• Attend Complaint Review meeting. Participate in failure analysis of Customer Returned Instrument to verify complaint and identify Product Quality improvement opportunities.
• Establish process Quality Control criteria and provide training to QC Technicians as needed.
• Monitor process, product quality and performance trend. Implement effective improvement initiatives to meet organization KPI targets. 
• Manage QC laboratory activities to support production. Maintain a validated QC laboratory including equipment trouble shooting if required. Identify opportunities to improve laboratory practices.
• Participate and review Site Process Validation activities to ensure Quality control adequacy.
• Generate weekly, monthly Quality performance reports for trend analysis and presentation in scheduled Management Review meeting.

What You Bring:

While this list of qualifications may help an employee to succeed in this position, capable candidates may have a wide range of backgrounds or skills. If you have experience that aligns with the responsibilities of this role, we encourage you to apply.

• Bachelor’s  Degree in Chemistry, Bio-Chemistry or Life Science.
• Min 3years of manufacturing quality control in a regulated environment with exposure to QC laboratory process is preferred.
• Experience in Process Validation, Non-conforming Process, Customer Complaint investigation.
• Experience with ERP systems a plus, SAP preferred.
• Knowledge of MDSAP and/or ISO13485 requirements. Preferable lead auditor certified.
• Knowledge of Good Laboratory Practice (GLP). Handling and disposal of Bio-Hazard materials.
• Hand-on experience of statistical tools application. Lean/ Six Sigma Green Belt preferred.
• Possesses excellent problem-solving, interpersonal, communication and leadership skills.
• Must be self-motivated, result oriented with minimal supervision.

Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. 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. Recently voted a Best Place to Work, Bio-Rad offers a 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.

Benefits: Bio-Rad's biggest asset is our people, and this is the reason why our Total Rewards deliver programs that provide value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Our 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. We’re proud to offer comprehensive medical plans and insurance, flexible benefits, wellness programs, extensive learning and development opportunities and more.

EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with disabilities, and people of all races, ethnicities, genders, ages, and orientations 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.

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