Production Quality Assurance Manager (f/m/x)

-; Hamburg; Hybrid; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading healthcare company is seeking a Production Quality Assurance Manager in Hamburg. This role involves ensuring that all diagnostic products meet rigorous quality standards and compliance. You will work collaboratively with production teams to manage nonconformities and conduct quality trainings. Ideal candidates will have a degree in a relevant field and extensive knowledge of ISO 13485. The position offers a flexible working environment and comprehensive benefits geared toward health and wellbeing.

Leistungen

Flexible working hours

Attractive compensation package

In-house gym

Career development opportunities

Subsidy for public transport

Qualifikationen

• Solid expertise in quality management within a regulated environment.
• Experience in implementing ISO 13485 or similar standards.
• Availability to work on-site with production teams.

Aufgaben

• Ensure production processes comply with quality standards.
• Review and approve QMS documentation.
• Conduct quality management trainings for production departments.

Kenntnisse

Quality Management

Process Validation

Hygiene Management

Strong Communication Skills

Proficiency in German

Proficiency in English

Ausbildung

Degree in Molecular Biology, Biotechnology, or Medical Technology

Tools

ISO 13485

IVDR

Jobbeschreibung

Are you looking for more than just a job, for something truly meaningful and rewarding? Then Sysmex Europe SE is the place for you. As the regional headquarters for the EMEA (Europe, Middle East and Africa) region, our company is dedicated to providing essential products that help people worldwide on their healthcare journey.

If this opportunity appeals to you, come and join us in the position of

Production Quality Assurance Manager (f/m/x)

Location Hamburg, Hamburg

Your responsibilities

What if you could be the one ensuring that every diagnostic product leaving our facilities is safe, reliable, and fully compliant with the highest quality standards? As a Production Quality Assurance Manager (f/m/x) for in‑vitro and molecular diagnostic production, you play a key role in safeguarding the integrity of Sysmex’s Life Science diagnostic solutions. You ensure that production processes run in line with rigorous quality and regulatory requirements, working closely with our production teams in Hamburg and Neumünster. Your key responsibilities include:

• Following up on production‑related nonconformities, supporting root cause analyses, defining and monitoring corrective actions, and preparing evaluations and statistics of nonconformities
• Managing production‑related change control, including moderating the change board and coordinating all related actions
• Conducting and managing quality‑management‑related trainings and providing general QA support to production departments
• Reviewing and approving QMS documentation in the Document Management System (DMS) as the final quality approver
• Performing incoming inspections (IQC), reviewing manufacturing documentation for IVD kits, labeling, and Instructions for Use (IFU), and verifying QC test data for individual components and master lot releases
• Managing and approving QA release activities, including preparation of the Device History Record (DHR), batch tree review, physical inspections of packed kits, and creation of Certificates of Analysis (CoA)
• Reviewing and approving validation and verification plans, protocols, and reports for cleaning, production, and testing processes
• Supporting cross‑functional initiatives aligned with quality requirements and continuous improvement goals
• Acting as a quality ambassador and providing guidance to stakeholders across production areas
• Supporting production teams during external audits, inspections, and third‑party assessments

Do you have questions?

Léa Sanft
[e-mail]
Reference No.: 10988

Your profile

You are a strong match for this role if you bring solid expertise in quality management within a regulated Life Science or diagnostic production environment and a deep commitment to ensuring product safety and compliance. Ideally, you bring the following qualifications and strengths:

• A completed education or degree in molecular biology, biotechnology, medical technology, or equivalent professional experience
• Profound knowledge of ISO 13485 and IVDR
• Proven experience in implementing ISO 13485 or other relevant standards
• Experience in production‑related topics such as hygiene management, process validation, or batch record review
• Dedication and diligence in Quality Management and Quality Assurance topics
• Strong communication skills and the ability to make consistent, professional decisions with a hands‑on mentality
• Excellent command of written and spoken German and English
• Availability to work on‑site with the production teams in Hamburg and Neumünster

Our benefits

• Culture & cooperation An appreciative work environment, open corporate culture, flat hierarchies and an inclusive and caring atmosphere. Working in an innovative and international environment with a broad learning and development landscape in our EMEA Campus, after‑work events for internal networking
• Work‑life balance Flexible working through flextime and a hybrid working model (60% mobile working, 40% on‑site), 30 days annual leave
• Additional benefits Attractive compensation package including Christmas and vacation pay, childcare allowance, capital‑forming benefits, subsidy for company pension scheme, corporate benefits, relocation assistance, subsidised lunch in our canteen
• Health & wellbeing In‑house gym, various sports courses, massages, company medical and psychological care, workplace glasses, general health management
• Mobility Subsidy for the public transport "Deutschlandticket", free parking, bike leasing via JobRad
• Social Responsibility Various opportunities to get involved in different sustainability and charity initiatives, climate friendly and respectful use of resources

Did we spark your interest? Then we look forward to receiving your application with salary requirements and the earliest possible starting date.