As a Senior/Staff Quality Engineer (m/f/d) focusing on Product Transfer, you will drive quality initiatives to enable successful transfers across global locations. This role combines strategic leadership with technical expertise to ensure compliance with internal and external quality standards, while delivering cost transformation and service improvements.
What you will do
* Support all global product transfers, including Supplier to Supplier, Supplier to Stryker, Stryker to Supplier, and Stryker to Stryker.
* Act as the point of contact for quality during the Scoping, Planning, and Execution phases of product transfers.
* Provide interpretation and guidance on quality-related regulations, corporate standards, and local procedures, including FMEA, MSA, Validations, and Qualifications.
* Review and approve Validation/Qualification documentation.
* Identify product transfer quality risks and provide effective solutions.
* Define quality strategies using a risk-based approach for FAI, Inspection Certification, and other key activities.
What you will need
Required Qualifications:
* A Bachelor’s degree in Engineering, Sciences, or a related field.
* 2–9 years of experience in quality and validation including quality concepts, risk-based techniques (e.g., FMEA, PPAP, Risk, Statistics), and global quality standards, including ISO 13485 and FDA 21 CFR Part 820.
* Demonstrated expertise in Validation, Qualifications, and Quality Systems.
Preferred Qualifications:
* Lean Six Sigma training or certification.
* Certification in Quality Management (CQE, CQA).
* Experience with QMS software and document control tools.
Diversity is important to us. We welcome applications from people regardless of their ethnic, national or social origin, gender, disability, age or sexual identity.
Additional information
This is an initially 12 months fixed-term role.
Thanks to our flexible working hours model, you will have the opportunity to work partially from the home office. However, a regular presence of 1 day a week on site at our location should be always given to build sustainable relationships and maintain personal contact with colleagues as well as the departments.
Please note that the internal job title may differ from the ad title.