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

Manufacturing Quality Engineer (M/F/D)

Location

Norderstedt, Schleswig-Holstein, Germany

Job Description

We are seeking a Manufacturing Quality Engineer to join our team in Germany.

The role focuses on supporting product and process changes throughout the lifecycle of commercialized products, ensuring compliance with company policies, quality standards, and regulatory requirements.

You will contribute to risk management, process improvement, inspection readiness, and support cross‑functional collaboration.

Responsibilities

• Support product and process activities throughout the product lifecycle and contribute to the effective operation of the Quality Management System.
• Apply quality engineering tools and methodologies to support development, transfer, implementation, and maintenance of products and processes.
• Contribute to risk management activities, process validation, process controls, and change management to ensure products meet quality and regulatory requirements.
• Support investigations, corrective and preventive actions (CAPA), and process improvement activities.
• Support inspection readiness and interact with regulatory authorities and notified bodies when required.
• Additional Responsibilities
• Implement and maintain Process Control Plans aligned with Quality Plans.
• Contribute to test method development, validation activities, process controls, and process risk management.
• Support validation strategies and ensure quality requirements are incorporated.
• Lead and/or support CAPA activities and implementation of corrective and preventive actions.
• Participate in product, process, manufacturing, and quality‑related projects.
• Apply quality engineering techniques such as risk analysis, statistical process control, statistical data analysis, test method development, and sampling plan development.
• Support effective change control processes.
• Participate in investigations of quality issues and implement 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, including agencies such as 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.

Requirements

• 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 (preferred).
• Experience in manufacturing and/or sterilization environments (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 language skills.
• Fluent English language skills.
• Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices.

What We Offer

We offer an environment that encourages learning, collaboration, and professional development.

You will have opportunities to contribute to meaningful projects, work with experienced colleagues, and build expertise within a global healthcare organization.

Benefits May Include

• 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.
• Commitment to Inclusion & EEO 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 or interview process, we will support you accordingly.

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