Design Assurance Engineer
Geplaatst op: 09-10-2019 | Solliciteren voor: 01-01-2020
Job Title: Design Assurance Engineer (1 FTE)
Location: Netherlands, Joure
Reporting to: QA Manager
Comecer Netherlands BV in Joure develops, produces and sells innovative instruments and software for Nuclear Medicine departments in hospitals and industry. Comecer Netherlands BV is part of the Comecer that is an ATS Automation company. Our products are sold worldwide.
We are searching for a Design Assurance Engineer who will be responsible for providing input into the quality and R&D team to ensures that compliance to all regulatory requirements is demonstrated.
Duty and Responsibility
- Review and approval of design and verification related documentation of our medical and not medical devices.
- Maintaining Technical Documentation (Design History Files), communicate product changes to Regulatory Authorities
- Ensures that all project related documents are created and well managed according to the regulation and internal quality standards.
- Ensures that project and quality documents are complete, current and stored appropriately.
- Guides the execution of (process) validations and associated tests to be performed in close collaboration with other related/relevant disciplines (including review and approval of documentation).
- Update clinical reports, Technical Documentation, Post Marketing Surveillance/Vigilance
- Monitoring changes in QA and RA regulations (Implement changes)
- Support the QMS as per ISO 13485 & FDA 21CFR820, with particular focus on CAPA system, Continuous Improvement activities, internal audit system.
- Approves design and quality documents related to design assurance and general quality management processes.
- Leads and participates in risk management and design review sessions with engineering teams.
- Registration of the product in different countries
Qualifications and / or Experience Required
- HBO/University in Engineering, Quality/Regulatory Affairs or a related discipline equivalent.
- Experienced regarding applicable quality system regulations and standards such as 21CFR820 and ISO 13485.
- 3-5 years of experience within a medical device company or highly regulated industry preferable in a QA & RA Compliance Officer role
- Regulatory affairs
- Knowledge of MDR is a pre
- Strong analytical skills and data-driven thinking.
- Experience in product development and life cycle management (product maintenance). Referable with software development and/or hardware/systems development.
Desired Skills and Experience
- Ability to communicate across levels of the organization and with customers
- Flexible, enthusiast and proactive
- Hands-on mentality to get the job done
- Excellent time management and organizational skills
- Excellent attention to detail in oral & written communication is a must, with a proven technical protocol & report writing background.
- Experience in active medical devices is considered a plus.
- Accurate and social
- Languages: Dutch and English
- Driving license B
What We Offer
- A challenging, varied and responsible job in a nice atmosphere with highly motivated colleagues
- A competitive salary and growth opportunities.
Send your motivation letter and CV no later than November 1st 2019 to HR department in Joure: firstname.lastname@example.org. Job interviews will be scheduled in November. By applying for this position you agree that we will provide your personal data to our internal stakeholders.