QA RA Manager Nordics
Company key words / products
Zimmer Biomet (ZB) is a leading medical device company - worldwide leader in musculoskeletal health care and has been since the founding more than 80 years ago.
Today, the global team of more than 16.000 employees works to provide effective, creative solutions that support orthopaedic surgeons and clinicians to restore mobility and treat arthritis and traumatic injuries. The joint replacement technologies and a wide range of related products and services make ZB a valuable partner to health care providers in more than 100 countries.
Zimmer Biomet Holdings: USD 7.933 B
Zimmer Biomet - Nordic: DKK 750 MIO / 150 employees
Zimmer Biomet Denmark ApS: DKK 200 MIO / 26 employees
Position / department staff / reporting
- QA RA Manager Nordics
- Nordic QA RA Team: 2 persons (FI / SE)
- Reporting to: QA RA Manager, North Europe.
Workplace - Herstedvang 12, 2620 Albertslund, Denmark
Startdate - ASAP
- Hands on function
- Act as Management Representative for the Nordic subsidiaries
- Guide and support the staff within the QA/RA organizations in the Nordic Countries
- Implement, maintain, review and develop the quality management systems in Nordics, in all relevant functions e.g. within sales organizations and warehousing
- Support optimized value creation to achieve economic success while assuring regulatory compliance respective to medical device requirements
- Perform instructed tasks of product surveillance.
- Manage the QA/RA function in the Nordic countries
- Represent the QA/RA function in Nordic Management review meetings
- Continuous process assurance and improvement
- Responsibility for maintenance, further development and documentation of the QM systems in the sales organizations in the region
- Business process analysis and coordination of all QA/RA related activities in above mentioned Zimmer locations
- Planning, coordination and performance of internal and external audits if needed also in additional European countries
- Supervision and handling of incoming complaints as well as coordination and performance of Field Actions instructed through headquarters
- Report and correction in case of incompliance with existing binding regulations
- Communication with authorities in coordination with headquarters
- Monitoring and report of new/changing regulations
- Participation in working committees and project groups of industrial associations.
Any other duties that may be required from time to time within the scope of this job description and qualified by prior training or experience.
The ideal candidate
- EDUCATION: BSc/MSc (or equivalent) in a technical discipline, preferably science – However, what’s important is your working experience
- EXPERIENCE: Solid background in DK / Nordic / European Regulatory Affairs, Regulatory compliance and Quality Management Systems with a minimum of 5 years experience in medical device regulatory / quality
- PEOPLE MANAGEMENT: Candidates with people management experience would be preferred. However, this is not a must.
- DETAILED KNOWLEDGE: ISO 13485 standard and the medical Device Directive / QMS and MDD now MDR (alternatively ISO 9001)
- AUDITING: Experience with ISO 13485 (alternatively ISO 9001)
- IT KNOW HOW: Excellent user level - MS Office / Excel / SAP + CRM Sales Force – NOT a MUST
- LANGUAGE: Speaking + writing Danish and English at a high level / Good understanding of SE & NO would be beneficial / FI know how would be great (NOT a MUST).
Technical skills and know how
Background in medical technology or healthcare industry
- Detailed knowledge of quality system and regulatory regulations in Europe
- Ability to prepare high quality, clear communication materials tailored to the appropriate audience
- Ability to function independently without extensive oversight
- Strong information management capabilities
- Problem solving skills.
- Strong skills in supervising projects and driving improvements activities in an organization.
- Mindset: Patient/Customer first!
- People management skills
- Inter-organizational teamwork
- Driving results and monitoring outcome
- High standard of attention to detail
- Continuous learning.
Travel requirements: Approximately 30 days annually
Residence: DK Copenhagen / Zealand Region - Driving distance from the ZB Albertslund office
Compensation: Competitive compensation package based on qualifications: Salary/Bonus program/Pension/Company car/LapTop/Mobile
Please forward your application / CV “QA RA Manager Nordics” via mail to firstname.lastname@example.org no later than Sunday 4th of August 2019. Interviews will be held continuously.
In case of any questions please contact Steen Storbjerg Nielsen: email@example.com / +45 2999 9689