Validation Manager

Senior Talent Partner | Medical Affairs | Clinical Affairs | Regulatory Affairs | Quality

🔹 The Role & Company

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.

🔸 As the V&V Manager your responsibilities will include, but not be limited to:

• Leading and controlling all V&V activities and processes
• Create, improve and approve validation protocols, process specifications, and V&V processes and documentation
• Role that allows personal freedom but also personal initiative to ensure high reliability, quality, confidentiality, efficiency, and delivery on deadlines
• Play a critical role in generating, reviewing, editing and approving qualification and validation / revalidation protocols, process specifications, FMEAs, test plans and summary reports
• Ability to influence the company’s quality systems and create new SOPs, CAPAs related to V&V and create new KPIs, documentation and protocols
• Work on V&V statistics and test data and set new KPIs within the organization
• Gain new perspectives from collaborating with experienced Quality and RA team members on EU, USA and Canadian regulations
• Work closely with the Global VP of QA+RA and high visibility to senior leadership
• Minimum 5 years in the medical device industry in Validation & Verification roles (for processes, software validation - CSV, and production equipment)
• Experience working under ISO 13485, MDR and FDA and QSR compliant environments
• Excellent communication skills in English and German

✉️ Interested to explore this further? Please send your CV to Frankie to arrange a confidential career discussion.

📲 Would you like to find out more about our open opportunities? Visit https://(Use the "Apply for this Job" box below)./

Only candidates meeting the requirements set out above will be considered in the application process. Due to the high volume of applications we receive, our team might not be able to contact each applicant individually regarding the status of their application. If you do not hear from us after 10 days, please consider your application unsuccessful.