Head of Quality (m/w/d) — Medizintechnik
Baden-Württemberg, Germany · Full Time
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- Experience
- 10 yrs
- Salary
- —
- Openings
- 1
- Posted
- 3 weeks ago
- Work mode
- In office
- Education
- Scientific or technical degree, or equivalent qualification
- Eligibility
- Candidates with substantial quality management experience in medical device manufacturing, including leadership responsibility, and strong German and English skills are suitable.
- Resume
- Required to apply
Job description
About the opportunity
We are seeking, on a confidential basis, a senior quality leader for a globally established manufacturer of medical technology products. The site in Baden-Württemberg is one of the company group’s most important locations and is looking for someone who will actively shape quality rather than simply administer it.
Your role
As Head of Quality, you will be part of the site leadership team and hold overall responsibility for the site’s quality management system within a global quality network. You will lead the QA/RA function, advise management on all matters related to quality, compliance and regulatory requirements, and help build a strong quality culture across the site.
Key responsibilities
- Drive the ongoing development, maintenance and performance of the site’s quality programmes and quality strategy.
- Lead and grow the QA/RA teams in both a professional and disciplinary capacity.
- Own internal and external audit activities, including customer audits, notified body audits and FDA inspections.
- Coordinate CAPA activities, change control workflows (ECR/ECN) and documentation processes.
- Prepare and present management review reporting to both site leadership and group management.
- Support international regulatory submissions and registrations, with a particular focus on the US market.
Your profile
- You bring roughly 10 years of quality management system experience in medical device manufacturing, including several years in a leadership role.
- You have strong working knowledge of ISO 13485 and 21 CFR 820; prior FDA inspection exposure is a plus.
- You have experience in computer system validation (CSV) and process validation methods such as IQ/OQ/PQ.
- You can point to successful international registrations, ideally including the US market.
- You hold a completed degree in a scientific or technical field, or an equivalent qualification backed by relevant experience.
- You communicate confidently in both German and English.
- Your leadership style encourages accountability, ownership and initiative.
What the company offers
- A key leadership position on the management team of a growing, future-proof site.
- An attractive compensation package consisting of base salary plus bonus.
- A permanent role with long-term development prospects within an international group.
Additional information
This is a permanent onsite position in Baden-Württemberg, Germany. The role is intended for a senior leader who will shape quality, compliance and regulatory performance at site level.