Quality Assurance Specialist (m / f / d)

The Quality Assurance (QA) Specialist (m / f / d) is the dedicated contact for the daily quality aspects on site. You work closely with senior QA specialists and supervisors for distribution and technical service. In this role, you will pilot the surveillance plan to ensure quality of the operative business to provide high quality products and services to Bio-Rad customers. Furthermore, you will ensure and support that the Quality Management System is aligned with regulatory and normative requirements, company requirements and customer satisfaction. QA Specialists also regularly propose improvement actions and follow their implementation (change control) and efficiency (KPIs). The successful candidate will be an active team member of the European Quality Department for Global Commercial Operations and Distribution. In this role, you will also be the proxy for the QA manager on site.

How You’ll Make an Impact :

• Follow-up on nonconform products and product returns in close collaboration with local and global Bio-Rad departments
• Support other departments with stock controls, batch corrections and extensions or rework activities
• Ensure and maintain product requirements according to their specifications for life science and medical devices (including reagents, devices, spare parts, consumables)
• Manage global stop shipments for the European Distribution Centers
• Perform traceability reports and support the follow-up guided by other Bio-Rad departments
• Pilot and follow-up surveillance plan of the site including transport temperature monitoring, conformity of the stock in terms of temperature, orientation, goods handling
• Follow-up on customer complaints and initiate CAPAs with relevant departments
• Provide quality trainings for newcomers and organize refresher sessions on a regular basis
• Support projects to implement improvements and changes into applicable procedures
• Support in follow-up on their efficiency with appropriate indicators and relevant documentation
• Support to maintain and continuously update SOPs, work instructions and the Quality Manual
• Ensure critical records are maintained in compliance with company and regulatory requirements
• Provide input to Quality Management Reviews and process reviews with local managers
• Participate in preparation, maintenance, and follow-up of internal and external audits for ISO 9001 and 13485

What You Bring :

• Bachelor's degree or equivalent in Life Sciences or a related field; or Bachelor's degree or equivalent in Quality Management or Quality Assurance with a focus on Life Sciences / Medical Devices
• Alternatively, strong professional experience of at least 2 years in a regulated environment in the area of Life Sciences / Medical Devices
• Initial work experience in Quality Management and / or Quality Assurance in Sales, Technical Service, Manufacturing or Logistics
• Experience following ISO 9001 & 13485 standards
• Spoken and written proficiency in German and English
• Experienced in using MS Office applications (Excel, Word, PowerPoint, Visio)
• Experience as an internal auditor and / or with medical devices is beneficial
• Knowledge of IVD-R or MDR as well as FDA 21 CFR part 820 is beneficial
• Proficiency in SAP and other relevant QA tools (eg. complaint handling, documentation management, temperature monitoring) is beneficial
• Ability to think analytically and work independently; accurate, flexible, proactive, communicative
• Team player; ability to listen and to propose good sense decisions
• Customer oriented with a service mentality
• Flexibility to travel occasionally; for trainings, team meetings and internal audits

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 thereason 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. Bio-Rad is proud to offer a comprehensive compensation program to attract, motivate and retain qualified employees. In addition to a competitive 13 month salary our employees can assess their contribution to the company's success through annual performance reviews. Our benefits include 30 days of paid time-off as well as a vacation allowance, on top of extensive learning and development opportunities, life and accident insurance, a pension scheme, capital-forming benefits, meal allowances, birthday vouchers, and regular team events. Family-friendly trust-based working time models and the option to work remotely allow for maximum flexibility.

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.

Quality Assurance Specialist • Kabelsketal, Sachsen-Anhalt, Germany, US