Validation Manager

Join a well established, growing and dynamic company designing, developing and producing a Class III active implantable medical device that changes the lives of patients.

This is a great opportunity to join a close knit team with one vision, surrounded by other senior experts in their field and the manufacturing shopfloor in the same building. You will work with some of the top Quality, Manufacturing, and RA teams with high risk device Class III experience, allowing you to develop your skills and further develop your career. This is a position reporting to the Vice President of QA, QM and RA so you can be sure that you will have an impact on patients’ lives and the company’s quality systems through your V&V activities and strategies.

As a V&V Manager, you’ll lead a range of responsibilities including testing protocols and creating statistical‑based V&V processes, as well as vigilance reporting in global markets such as the USA, Canada and Europe.

You will be given freedom and responsibility to improve the Quality Systems by creating new SOPs, new testing and calibration protocols for the company, through your expertise in V&V activities.

Responsibilities and Qualifications

• Leading and controlling all V&V activities and processes
• Creating, improving and approving validation protocols, process specifications, and V&V processes and documentation
• Ensuring high reliability, quality, confidentiality, efficiency, and delivery on deadlines through personal initiative
• Generating, reviewing, editing and approving qualification and validation/revalidation protocols, process specifications, FMEAs, test plans and summary reports
• Influencing the company’s quality systems by creating new SOPs, CAPAs related to V&V and new KPIs, documentation and protocols
• Working on V&V statistics and test data and setting new KPIs within the organization
• Gaining new perspectives from collaborating with experienced Quality and RA team members on EU, USA and Canadian regulations
• Working closely with the Global VP of QA+RA and maintaining high visibility to senior leadership
• Having a minimum of 5 years in the medical device industry in Validation & Verification roles (for processes, software validation – CSV, and production equipment)
• Having experience working under ISO 13485, MDR and FDA and QSR compliant environments
• Demonstrating excellent communication skills in English and German

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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