About This Role
Qualit y control specialists ensure the quality of products by working with production, engineering, and supplier teams. This role involves monitoring data, implementing improvements to meet regulatory and organizational objectives, and supporting QC instrument testing.
Responsibilities
- 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
Requirements
- Bachelor’s Degree in Chemistry, Bio-Chemistry or Life Science
- Minimum 3 years 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
Benefits
- Comprehensive medical plans and insurance
- Flexible benefits
- Wellness programs
- Extensive learning and development opportunities
About the Company
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, they are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. They help people everywhere live longer, healthier lives and have been voted a Best Place to Work.
