3x Manufacturing Quality Engineer (M/F/D)

Job Summary

We are looking for a Manufacturing Quality Engineer (M/F/D) to join our team in Norderstedt, Schleswig-Holstein, Germany.

This role supports product and process changes throughout the lifecycle of commercialized products, ensuring compliance with company policies, quality standards, and regulatory requirements while contributing to risk management, process improvement, and inspection readiness.

Key Responsibilities

• Support product and process changes throughout the product lifecycle, ensuring compliance with company policies and regulatory requirements.
• Contribute to the operation of the Quality Management System.
• Apply Quality Engineering tools and methodologies to support development, transfer, implementation, and maintenance of products and processes.
• Lead and/or support CAPA activities and implementation of corrective and preventive actions.
• Participate in product, process, manufacturing, and quality‑related projects.
• Apply risk analysis, statistical process control, statistical data analysis, test method development, and sampling plan development.
• Support effective change control processes to ensure changes are appropriately assessed, documented, and implemented.
• Participate in investigations of quality issues and support the implementation of effective corrective and preventive actions.
• Support inspection readiness activities and maintain compliance with applicable quality requirements.
• Collaborate with internal and external teams to support compliance and regulatory requirements.
• Support interactions with regulatory authorities and notified bodies, including FDA, ANVISA, and BSI.
• Follow environmental, health, and safety requirements and support a safe working environment.
• Communicate significant business, quality, or compliance issues to the appropriate management level when needed.
• Ensure personal and company compliance with all applicable regulations, policies, procedures, and standards.

Qualifications & Experience

• Bachelor’s degree or equivalent in Engineering, Life Sciences, Pharmacy, Physical Sciences, or a related discipline.
• At least two years of experience in a regulated healthcare industry such as pharmaceuticals, biologics, medical devices, or a related field.
• Experience in manufacturing and/or sterilization environments is desirable.
• Understanding of quality systems and applicable regulatory requirements.
• Knowledge of quality engineering principles, risk management methodologies, and process improvement concepts.
• Experience supporting investigations, CAPA activities, process validation, and change control processes.
• Strong analytical, problem‑solving, and decision‑making skills.
• Experience with statistical tools and methodologies; Six Sigma Green Belt or comparable certification is beneficial.
• Ability to work collaboratively across functions and manage multiple priorities in a dynamic environment.
• Strong communication and interpersonal skills.
• Fluent German and English language skills.
• Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity.

Benefits

• Competitive salary and annual incentive opportunities.
• Health and wellbeing programs.
• Learning and development opportunities.
• Career growth and internal mobility programs.
• Employee resource groups and inclusion networks.
• Retirement and savings programs where applicable.
• Flexible working arrangements where applicable.
• Opportunities to work on local and global initiatives.
• Supportive and team‑oriented work environment.
• Equal Employment Opportunity Statement

We are proud to be an equal opportunity employer and welcome applications from all qualified candidates.

Employment decisions are made without regard to legally protected characteristics.

If you require a reasonable accommodation during the application, interview, or onboarding process, support is available.

We strive to offer a workplace that is as barrier‑free as possible and provide special consideration to severely disabled applicants who are equally qualified.

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