Overview
Head of Quality Control Jobs in Dortmund, North Rhine-Westphalia, Germany at Established Search
Title: Head of Quality Control
Company: Established Search
Location: Dortmund, North Rhine-Westphalia, Germany
Head of Quality Control & Assurance (m/f/d)
Location: Greater Dortmund Area, Germany (On-site)
We have partnered with an innovative ophthalmology-focused medical device manufacturer to appoint a Head of Quality Control & Assurance (m/f/d).
Operating within a highly regulated cleanroom manufacturing environment, our client develops and manufactures products that support eye care professionals and patients worldwide. This is a senior leadership opportunity for an experienced quality professional to lead both Quality Control and Quality Assurance activities, drive continuous improvement initiatives, and ensure compliance within an MDR-regulated environment.
Key Responsibilities
- Lead and further develop the Analytical and Microbiological Laboratory functions.
- Manage and mentor the Quality Assurance team, currently consisting of five employees.
- Ensure the timely execution of testing, release activities, and quality approvals in accordance with regulatory and internal requirements.
- Drive the implementation of MDR requirements and continuously improve quality systems and operational processes.
- Oversee CAPA activities, change control processes, complaint investigations, and SOP management.
- Support qualification and validation activities for equipment, systems, and analytical methods.
- Review and approve specifications, sampling plans, testing procedures, and related quality documentation.
- Deliver quality-related training across the organisation.
- Represent the quality function during internal, external, customer, and regulatory audits.
- Collaborate closely with Manufacturing, R&D, Regulatory Affairs, and Quality Management teams.
Candidate Profile
- Degree in Pharmacy, Chemistry, Biology, Medical Technology, Life Sciences, or a related scientific discipline.
- Several years of leadership experience within Quality Control and/or Quality Assurance in a regulated medical device, pharmaceutical, biotech, or life sciences manufacturing environment.
- Strong analytical expertise, including testing of raw materials, components, and packaging materials.
- Comprehensive knowledge of the European Medical Device Regulation (MDR).
- Experience working within GMP and related quality frameworks is advantageous.
- Proven ability to lead, develop, and motivate quality teams.
- Strong decision-making, communication, and problem-solving skills.
- Comfortable working within a sterile Class C/D cleanroom production environment when required.
- Fluent German and English, both written and spoken.
- Proficient with Microsoft Office applications.
