Overview:
The QC Specialist is responsible for timely review, confirmation, disposition, and resolution of nonconforming materials in accordance to established NC process to meet quality targets. You will investigate instrument complaints, pursue containment action, root cause identification and corrective actions. You will also execute continual improvement initiatives to meet organization objectives, support IQC process and participate in Supplier Improvement Initiative and will also support and execute installation qualification and maintenance of QC ancillary equipment.
How You’ll Make an Impact:
- Responsible to verify and confirm supplier material defects in daily walk-the-line. Ensure defects are adequately investigated with supporting reports.
- Drive cross functional teams in nonconformance investigation. Review Quality Notification activities for timely defect disposition. Responsible to ensure all QN tasks are adequately completed before closure.
- Investigate instrument complaint, established immediate containment, identify root cause and implement correct action.
- Engage cross functional team to improve QC test First Pass Yield. Participate in continuous improvement initiatives.
- Support IQC process with specification review and Quality Inspection Plan set up.
- Support QC Lab equipment validation, calibration, and preventive maintenance.
- Generate weekly, monthly QN reports for trend analysis and presentation in scheduled Management Review meeting. Drive QN closure to meet aging and defect cost targets
- Participate in Product Transfer Initiative – New or existing products from other sites. Review QC test procedure for adequacy
What You Bring:
- Bachelor’s degree in Mechanical or Electrical Engineering or Diploma in Mechanical or Electrical Engineering with minimum 5 years of Quality Engineering experience or demonstrated competency.
- 1 - 3 years of manufacturing quality assurance / control /engineering experience in a regulated environment preferred
- Knowledge of ISO 13485 MDSAP requirements. Lead Auditor preferred
- Experience in Process Validation, Non-conforming Process, Customer Complaint investigation.
- Possesses excellent problem-solving, interpersonal, communication and leadership skills.
- Must be self-motivated, result oriented with minimal supervision.
- Hand-on experience of statistical tools application. Lean/ Six Sigma Green Belt preferred.
- Experience with ERP systems a plus, SAP preferred.
- 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.
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.