QA Tester enhancing quality in games at FuturLab, an award - winning game studio. Focus on executing tests, logging defects, and improving user experience.
About the role
- Senior Quality Engineer ensuring successful execution of global manufacturing transfers and compliance with quality regulations in the medical device sector.
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
Requirements
- 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
Benefits
- Health insurance
- 401(k) plan
- Paid time off
- Hybrid work arrangements
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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