- Working knowledge of Change Control/Management, Validation and Post Market Surveillance.
- Thorough understanding of Medical Device Reporting, cGMP, QSR, ISO-13485, ISO-14971 and ISO-62366 regulations and standards is preferred.
- Knowledge and understanding of CAPA and associated investigation tools.
- Understanding of statistical methods, statistical process control and sampling plans.
- Quality Engineering, Six Sigma Green or Black Belt Certification preferred.
- Knowledge/experience in medical device, drug or biotech manufacturing a plus.
- Detail oriented with excellent organizational and project management skills.
- Excellent verbal and written communication, problem solving, analytical skills required.
- Critical thinking skills, ability to multitask in a high-pace environment with fast deadlines, and ability to work well under pressure.
- Working knowledge of MS Word, MS Excel, MS PowerPoint, Minitab.
- Knowledge/experience with SAP and/or Salesforce systems a plus.
Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 7,800 employees and a global network of operations serving our customers, we help people live longer, healthier lives.
Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.
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.