Qualitätsmanager / Senior RA/QA Specialist (m/f/d)

Founded in 1952, Bio-Rad has developed into a recognized global leader in the growing life science research and clinical diagnostics markets. We have built a strong team of over 8,000 employees and a robust network of operations that serves over 150,000 customers worldwide. Bio-Rad employees share a common mission: To "Advance discovery and improve lives." It is who we are and what we do. In order to support Bio-Rad and our successful future growth we are seeking a highly motivated and experienced individual to join our team. The successful candidate will have the opportunity to make significant contribution within our dynamic and growing international team. 

For our new Warehouse and Technical Service site in Grosskugel near Leipzig/Halle we're looking to hire a Senior RA/QA Specialist / Qualitätsmanager (m/f/d)

Activities and responsibilities

Position Summary
In alignment with regulatory and normative requirements, company requirements and customers satisfaction, the Senior RA/QA Specialist maintains the quality management system (QMS) for our distribution organization, including preparation of relevant documentation and records. The successful candidate promotes best practices to achieve organizational efficiency, works closely with supervisors and managers and supervises and backs up a junior QA specialist. Furthermore, the Senior RA/QA Specialist participates in internal audit programs on European level and is involved in projects in line with company objectives. The Senior RA/QA Specialist reports into the Quality Assurance Manager. 

Tasks & Responsibilities
• Quality Assurance (QA) and management
o Pilot the quality documents process: quality manual, SOPs and work instructions
o Conduct working groups to implement improvements into applicable procedures; follow-up their implementation and their efficiency with the appropriate indicators
o Responsible for the Quality Management Review organization with the local management board: propose Quality policy related to the company objectives, changes of organization or changes of external regulations; lead the review and follow the realizations of the actions decided by management board
o Identify improvement opportunities by conducting internal audits and through the analysis of customer feedback and KPI data; support the business in defining corrective actions and improvement activities
o Manage external audits by regulatory bodies and customers on site for ISO 9001 & ISO 13485
o Participate and assist in business risks management activities

• Follow-up on nonconformities, CAPA and product returns
o Manage the surveillance plan of the site (e.g. temperature monitoring during shipment, temperature control of products at arrival, conformity of the stock in terms of temperature, orientation, goods handling etc.)

• Support other departments with tasks e.g. stock controls, batch corrections & extensions; ensure and maintain product requirements according to their specifications for life science and medical devices (e.g. reagents, devices, spare parts, consumables), including on-call duty for the temperature monitoring system

• Regulatory Affairs (RA)
o Manage stop shipment and traceability report for the Distribution Center
o Ensure that critical records are maintained in compliance with company and regulatory requirements

• Active European QA/RA team member that gets involved in projects according to company objectives
o Participation to the internal audit program
o Involvement in projects in line with objectives to build the European QMS
o Ensure business continuity of QA activities in case of absence

Qualification profile

Key Qualifications
• Master's degree (or equivalent) in Life Sciences, Medical Devices or related field; or Master's degree (or equivalent) in Quality Management with orientation towards Life Sciences / Medical Devices
• Relevant professional experience in Quality Management / Assurance in Distribution, in Sales, Technical Service, Manufacturing or Logistics
• Experience following ISO 9001, 13485, 14001 procedures
• Proficiency in German and English
• Proficiency using MS Office applications and SAP, as well as other relevant tools (Sales Forces, Ennov, Visio)
• Managerial experience
• Experience as an internal auditor is beneficial
• Experience with medical devices is beneficial

Required Skills
• 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 and internal audits

Benefits

• Competitive 13 month salary
• 30 vacation days p.a.
• Vacation allowance : 750,- EUR gross p.a.
• Meal allowance: 720,- EUR net p.a., including a modern kitchen area for shared meals
• Marriage and/or birth allowances: 150,- EUR gross
• Amazon Birthday voucher: 20,- EUR net
• Annual performance and salary review
• Pension scheme and capital-forming benefits
• Regular informational and team events
... as well as ample opportunity for growth and training, the stability of a profitable 60+ year old company and a great work environment.

Note this time limited position will provide maternity leave coverage of a team member, starting in Q2 2019 for a term of approx. 12 months.

Send application to

Next Steps
If you are interested in this role, click ‘Apply’ with an updated CV. If this role isn’t right for you, feel free to ‘Refer a Friend’.
Please apply online and in English by uploading your CV and cover letter including your earliest possible start date and salary expectations.
Bio-Rad is an equal opportunities employer and welcomes applications from all members of society irrespective of age, sex, disability, sexual orientation, race, religion or belief.

By submitting your resume and application information, you authorize Bio-Rad to transmit and store your information in the companies' world-wide recruitment database, and to circulate that information as necessary for the purpose of evaluating your qualifications for this job. Note: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Bio-Rad will not pay for any fees related to unsolicited resumes.

https://apptrkr.com/1417602

While applying for the job please refer to jobvector and use the following reference number: 2019-9544

About Bio-Rad Medical Diagnostics GmbH

Bio-Rad Laboratories Logistik GmbH ist eine Tochter des Bio-Rad Konzerns, eines führenden Unternehmens im Bereich Life Science und Diagnostica mit weltweit über 7.700 Mitarbeitern. Bio-Rad Laboratories entwickelt, produziert und vertreibt Geräte, Reagenziensets und Verbrauchsmaterialien für die molekularbiologische und biochemische Forschung in Life Science sowie für die klinische Diagnostik.

More about Bio-Rad Medical Diagnostics GmbH