Bio-Rad is seeking an experienced Quality Manager to join the Northern California Quality Assurance team to support instrument and consumables manufacturing as well as the Service and Support organization.
- This Quality Manager will be responsible for implementing and maintaining effective quality system processes, providing quality oversight, and developing and leading the Quality Assurance function for discrete instrument, regulated consumable manufacturing and service and support operations.
- This individual will function in a management role and must demonstrate excellent leadership, communication, critical thinking, and organizational skills.
- It is expected that the incumbent will lead a high-performing, team-based organization in a matrix environment where colleagues are flexible, multi-skilled and empowered to make decisions appropriate for their level.
- The position requires thorough knowledge and experience with regulated manufacturing environments that meet ISO 13485 and FDA GMP requirements.
- Leadership and development of core QMS processes and resulting documentation will also be a primary focus for this role.
- As QMS Management Representative, this role will interact with outside regulatory agencies and other external parties in support of inspections and audits.
- This position will also liaise with other QA Manager peers located in the US, Singapore, Belgium and France to ensure local improvements align with Bio-Rad global best practices.
- Bachelor’s degree or equivalent in Biology, Chemistry, or related field.
- 5+ years’ experience in a regulated manufacturing industry or equivalent combination of education and experience.
- Experience supervising/managing employees and quality systems programs in a regulated environment.
- Full knowledge of GMP/ISO regulations (ISO 13485, ISO 14971, MDSAP, IVDD, IVDR and FDA 820).
- ISO Auditor certification highly desirable.
- Experience with risk management, failure investigations, validation, and change control in a highly regulated environment.
- Detail-oriented, excellent organization and project management skills are needed to meet expectations.
- Decision making, time management, communication, leadership, and computer skills.
- SalesForce, SAP and Power BI experiences, quality manager, quality engineer, Six Sigma Green or Black Belt certification is 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 8,000 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.