(Senior) QA Officer - Amsterdam
Vacancy information
| Publication date: | January 12 2021 |
| Employment type: | Permanent |
| Sector: | Medical Devices |
| Function Group: | Quality/RA |
Functiegroepen: Quality/RA / QA Officer
Organisatie
For a global market leader in the field of cancer diagnostics, we are currently looking for a (Senior) QA Officer for their site in Amsterdam. The company operates in over 100 counties and has manufacturing facilities in 9 countries.
Functie
In this role, you will be responsible for maintaining daily quality operations in compliance with applicable regulatory requirements and standards and requirements. You will support QMS conversion to IVDR as per determined LBS-AMS IVDR implementation plan. The will be a close collaboration with the QRA team and all site functions to support all activities related to IVDR transition. Other responsibilities include:
- Chair of CAPA, NC and CC Review Boards
- Responsible for the site compliance plan, management review, and KPI reporting
- Support / Lead the internal audit program by creating/maintaining audit schedules for the current QMS as well as for IVDR-compliant QMS
- Mentor junior staff and provide education/ training to other functions on regulations and quality system designed as per IVDR, ISO 13485, CFR 21 Part 820
- Host / Co-host regulatory, corporate, and customer audits; monitor and improve audit readiness; ensure backroom preparations
- Support and develop working relationships with cross-functional teams including R&D, manufacturing, procurement, logistics, and product management to ensure process solutions are compliant to applicable regulatory requirements and the company QMS
- Support preparation of the Quality System Management Review; deputise for chairing the management review meeting
- Interact with global Quality counterparts within ASI and LBS to ensure benchmarking with the best Quality System processes
- Maintain and develop working knowledge of relevant regulations and quality system requirements that impact the business
- Other duties as assigned by Sr QRA Manager and as required to maintain successful continuous operation of business
Functie-eisen
Required Skills/Experience:
- Bachelor’s degree in science, medical or technical field and 5+ years’ experience with increasing responsibility in IVD and/or medical device or pharma industry in QA and/or QC functions
- Graduate degree in science, medical or technical field and 3+ years’ experience with increasing responsibility in IVD and/or medical device or pharma industry in QA and/or QC functions
- Full professional proficiency in English
- Highly desirable – advanced knowledge of the new EU device regulations – IVDR and/or MDR
- Desirable – experience working in the laboratory and/or QC laboratory
- Experience in the IVD industry is preferred
- Formal certification in auditing to ISO13485 and regulatory requirements for EU and USA is preferred
Competencies:
- Demonstrated success performing a wide range of quality system related activities as listed above in the responsibilities section
- Strong organisational and analytical thinking skills
- Ability to multitask
- Hands-on and can-do attitude
- Strong writing skills and ability to use appropriate software tools to develop and edit documents, procedures, reports
- Exceptional communication skills (verbal/written/presentation/relationship building)
- High level of initiative, self-motivation, and energy
- High level of integrity
Aanbod
The organisation can offer you a competitive offer with a bonus scheme and a non-contributory pension. Salary range will be between 55K – 70K based on background and relevant experience.
Sollicitatie
If you are interested in this job, or in similar ones, please feel free to contact me directly.
Daniel Donker
Principal Consultant | Biotech & Pharma
+31(0)6-82564401
+31(0)23-7548660
d.donker@qtcrecruitment.com