Senior Quality Engineer - Product Transfer (fixed-term contract)

PowerToFly; Freiburg im Breisgau; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A leading medical technology company is seeking a Quality Assurance Specialist for a 1-year fixed-term contract in Freiburg im Breisgau. The role focuses on supporting global manufacturing transfers, ensuring regulatory compliance, and enhancing quality initiatives. Candidates should have a degree in Engineering or Science, with at least 2 years of Quality Assurance experience, preferably in the medical device or pharmaceutical sector. Fluency in English is required, alongside knowledge of regulatory standards like ISO 13485. This position offers a chance to directly impact healthcare outcomes.

Qualifikationen

• 2+ years of experience in Quality Assurance and validation in medical device or pharmaceutical industry.
• Strong knowledge of ISO 13485 and FDA 21 CFR Part 820 regulatory standards.
• Fluent in English.

Aufgaben

• Support manufacturing transfers, including supplier and inter-site transfers.
• Review and approve validation and qualification documentation.
• Act as the Quality Assurance point of contact during transfers.
• Provide quality guidance on regulatory standards.
• Identify quality risks and propose mitigation solutions.
• Collaborate with multiple divisions and contribute to quality best practices.

Kenntnisse

Quality Assurance

Validation

Regulatory Compliance

Risk Management

Project Management

Communication

Detail Oriented

Ausbildung

University degree in Engineering, Science or a related field

Jobbeschreibung

Within the QA Shared Services – Product Transfer team, you will play a key role in the successful execution of global manufacturing transfers. You will ensure regulatory compliance, support validation activities, and contribute to continuous improvement initiatives to deliver efficient transfers in terms of quality, cost, and timelines.

This is a 1-year fixed-term contract as part of a maternity leave replacement, with the possibility of extension.

Key Responsibilities

• Support all types of manufacturing transfers, including supplier-to-supplier, supplier-to-Stryker, Stryker-to-supplier, and inter-site Stryker transfers
• Review and approve validation and qualification documentation
• Act as the Quality Assurance point of contact during scope definition, planning, and execution of supplier transfers
• Provide quality guidance related to applicable regulations, standards, and procedures
• Identify potential quality risks during transfers and propose effective mitigation solutions
• Collaborate with multiple divisions (T&E, Joint Replacement, Endoscopy) and contribute to quality best practices across the organization

Candidate Profile – Required Qualifications

• University degree in Engineering, Science or a related field
• Minimum 2 years of experience in Quality Assurance and validation, preferably in the medical device or pharmaceutical industry
• Strong knowledge of quality concepts, risk management tools, and regulatory standards (ISO 13485, FDA 21 CFR Part 820)
• Fluent in English

Preferred Qualifications

• Experience with Quality Management Systems (QMS) or Supplier Quality
• Excellent communication, presentation, and project management skills, with strong attention to detail
• Lean Six Sigma certification (ideally Green Belt)

Join an international and regulated environment, at the heart of high-impact quality transfer projects, contributing directly to the improvement of healthcare.

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.