Quality Sys Spec II

Overview:

The Quality System Specialist supports and performs activities associated with processes that make up the Quality Management System (QMS). This includes but is not limited to change control, CAPA, audit (internal/external) and management review meeting.

How You'll Make an Impact:

• Manage the change request process, ensure timely review and arrange change control meetings to review changes related to design, manufacturing processes, product design and documentation. Collaborate with internal stakeholders (e.g., Manufacturing Engineering, Quality Control, Value Engineering) and external stakeholders (e.g., R&D, Regulatory Affairs) to assess change impact and ensure alignment.
• Support and co-manage the Corrective and Preventive Action (CAPA) process with CAPA owners, ensuring root cause analysis, action plan development & execution and effectiveness checks, and timely closure.
• Prepare and organize materials for periodic management review meetings in accordance with ISO 13485:2016. Coordinate meeting logistics, scheduling, and follow-up actions to ensure effective review and decision-making.
• Provide active support during internal audits and external audits/inspections (e.g., Certification Body, MDSAP), including front room and war room roles. Ensure audit readiness by maintaining up-to-date documentation and records.
• Support the maintenance and improvement of QMS processes including Document Control, Change Control, CAPA, Internal Audit, and Management Review. Ensure alignment with ISO 13485:2016 and MDSAP regulatory frameworks across participating countries (e.g., US FDA, Health Canada, TGA Australia, ANVISA Brazil, PMDA Japan).

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 or equivalent in a related life science/technical discipline or equivalent preferred.
• ISO 13485:2016 Lead Auditor certified preferred
• At least 2+ years experiences in a regulated manufacturing industry or equivalent combination of education and experience.
• Experience with QMS Databases (i.e., Veeva, SAP).
• Understanding of GMP and quality system standards as they apply to products manufactured by Bio-Rad.
• Strong communication and coordination skills across cross-functional and global teams.
• Decision making, time management, organization and computer skills.
• Working knowledge of In-Vitro Diagnostic Device/Medical Device/Biotech manufacturing processes.
• Detail-oriented and ability to multitask.

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.