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Sr. QA/RA Engineer
LocationHoofddorp, the Netherlands
Seniority levelExpert level
Education levelMaster degree
OMRON Healthcare Europe is looking for a Senior QA/RA Engineer to join our strong European Quality Assurance & Regulatory Affairs department. We offer you the opportunity to be part of our important mission to help realize healthier and comfortable lives for people around the world.
We are looking for an energetic, intelligent and hardworking individual with high integrity and extensive knowledge of the Quality Management Systems under ISO 13485, with strong project management skills and willingness to grow further in the medical devices QA/RA domain to join our team.
The Sr. QA/RA Engineer based in Hoofddorp, The Netherlands, operationally manages and controls the activities related to the development, certification, maintenance, continuous improvement, simplification and compliance of the OMRON Healthcare (OHE-G) Quality Management System to ensure it conforms to the applicable medical device and non-medical device standards and regulatory requirements for our business. The Sr. QA/RA Engineer is capable of leading projects, identifying and analyzing Quality and Regulatory risks in projects and ensures these are mitigated or brought back to acceptable levels.
- Operationally manage and control the activities related to the development, maintenance, continuous improvement, simplification and compliance of the OMRON Healthcare Group (OHE-G) Quality Management System following the business development of OHE-G.
- Supervise, manage and close internal and external non-conformities, as well as manage post market surveillance activities, such as customer claims and complaints, including nature/cause/effect analysis and coordinate, monitor and report on the effective and on time implementation of Corrections and Corrective & Preventive Actions.
- Create, review, revise, implement and approve Standard Operating Procedures (SOP’s), Work Descriptions and other quality documents cross-departmental. Act as internal consultant for the development of SOP’s, Work Descriptions and other quality documents to other departments for both ISO 13485 and non-ISO 13485 related business processes.
- Ensure all systems, processes and activities within the company meet set requirements or applicable standards (e.g. software validation activities as per ISO 13485, supplier quality control, quality inspections etc). Moreover, supervise Quality Assurance activities related to the Incoming Inspection process (i.e. preparation of work descriptions, troubleshooting, execution and reporting of incoming inspection process and results).
- Lead and provide support during internal and external audits. Manage internal and external audit non-conformities.
Desired Skills and Experience
The ideal candidate would have:
- Master’s degree
- At least 5 years of experience in the QA/RA domain
- Extensive experience and knowledge of the Quality Management systems under ISO 13485 (Lead Auditor Certification is desirable)
- Risk management (ISO 14971) knowledge
- Demonstrated knowledge of the Medical Device Directive 93/42/EEC and the Medical Device Regulation 2017/745 and other medical device related regulations and directives
- Excellent knowledge of Microsoft Office (Word, Excel, Outlook, PowerPoint)
- Analytical individual with strong Excel skills
- Strong project Management skills, ability to be project leader
- Proficient in the English language, both written and verbal (knowledge of other European languages is also welcome)
- Good (interpersonal) communication skills
- Knowledge of the RoHS Directive and REACH regulation is desirable
- Experience with medical device labelling, Unique Device Identification (UDI) and medical device traceability requirements is desirable
- Knowledge of Lean Six Sigma and process optimization is desirable
OMRON core competencies:
- Passionate about customers
- Making it happen
- Total team players
- Team leaders
Want to apply?
- A resume is required – this resume should be in English