Quality System Specialist

In alignment with Global RA/QA strategic aims, this position is responsible for the Quality Management System of Bio-Rad Oxford and Bio-Rad Neuried facilities to ensure the QMS is maintained in compliance with all applicable quality and regulatory requirements. The role will promote best practices to achieve process efficiencies, to ensure customer satisfaction and optimal value to the business. The role will be based in Oxford, UK, and will participate in active collaboration with Bio-Rad’s EMEA RA/QA Organisation. This is an office-based full-time permanent position at our manufacturing facility in Kidlington, near Oxford.

How You’ll Make an Impact:

• Maintenance and improvement of the Quality Management Systems (ISO 9001) in alignment with Global RA/QA goals and Oxford business needs.
• Manage the document control process: Quality Manual, procedures, and work instructions.
• Identify and implement improvements in applicable procedures; monitor and measure post-implementation with the appropriate indicators.
• Plan and lead applicable quality reviews with local managers and ensure any resulting actions taken have been effectively implemented.
• Report to management on the performance of the QMS and any need for improvement, through ownership, and contribution to, KPI dashboards.
• Mentor and train employees on the QMS, work collaboratively with business partners on quality requirements and changes in the regulatory landscape.
• Identify improvement opportunities by conducting internal audits and from the analysis of customer feedback data and KPIs. Support the business to define corrective and preventive actions and improvement activities.
• Manage external audits by Notified Bodies and customers.
• Deliver and manage the Oxford local internal audit program as lead auditor. Support a local team of internal auditors.
• Works closely with R&D, Tech’ Transfer, Manufacturing, Logistics and Facilities to resolve product and process quality issues.
• Ensure that Quality obligations for suppliers, vendors and partners are managed effectively.
• Remain current on evolving QMS trends and product regulatory requirements.
• Support Bio-Rad QA-related projects according to defined objectives, to maintain and improve the QMS provision.

What You Bring:

• Education: Bachelor’s degree or equivalent in a related life science/technical discipline or equivalent, with further education a plus.
• Minimum 8 years QMS experience in an ISO9001 or ISO13485 environment, medical device or life science preferred.
• Strong working knowledge of ISO9001. Additional knowledge of ISO13485 a plus.
• Proven experience with CAPA, Documentation Management, Change Control, Training.
• QMS auditing experience, certified quality auditor preferred.
• Detail-oriented, critical thinking, and ability to multitask.
• Strong problem solving, decision making, time management, organization, communication, leadership, and computer skills.
• Proven leadership and influencing skills in a cross-cultural, matrixed organization.

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 its people, and the reason why our Total Rewards deliver programs that provide value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Our robust 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 a variety of options in the UK including competitive salary, commission plan, salary review, pension matched up to 8%, private health & dental insurance with Bupa, bonus scheme, life insurance & income protection, 25 days holiday plus an extra day off on your birthday, Help@Hand (a 24/7 online GP, physio, mental health support & virtual wellbeing program), Training & Development programs with access to LinkedIn Learning, Cycle to Work scheme, free on-site parking, employee High Street shopping discounts, gym membership discounts and employee referral scheme.

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 authorised by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorised to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.