Senior Staff Quality Engineer, Product Transfer (mfd)
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
As a Senior/Staff Quality Engineer (m/f/d) in Strykers Product Transfer Quality Engineering function you will play a key role in ensuring seamless product transfers driving quality excellence cost optimization and service improvements that directly benefit our customers.
You will be an integral part of the QA Shared Services Product Transfer Team collaborating across functions to support all quality-related activities and ensure compliance with both internal and external standards.
What you will do
Support all production transfers globally (Supplier to Supplier Supplier to Stryker Stryker to Supplier Stryker to Stryker)
Review and approve Validation and Qualification documentation.
Act as the QA point of contact during the Scoping Planning and Execution of the supplier transfer.
Provide quality guidance related to relevant regulations corporate standards and procedures (e.g. FMEA MSA Validations).
Identify potential quality risks during the transfer and propose effective solutions.
Define QA strategies using a risk-based approach for FAI inspection methods and other key quality activities.
What You Will Need
Required Qualifications:
Bachelors degree in Engineering Sciences or a related field.
Minimum of 2 years experience in quality assurance and validation ideally within the medical device or pharmaceutical industry.
Strong knowledge of quality concepts risk management tools (e.g. FMEA PPAP) and regulatory standards (ISO 13485 FDA 21 CFR Part 820).
Proficiency in English & German
Preferred Qualifications:
Experience in supplier quality and Quality Management Systems (QMS).
Hands-on experience with product transfers in regulated environments.
Excellent communication presentation and project management skills with strong attention to detail.
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
The position is initially limited to 18 months. Due to the large number of different positions and areas of responsibility Stryker often offers the options of being taken on in a permanent position.
Thanks to our flexible working hours model you will have the opportunity to work partially from the home office. However a regular presence of 2 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.
Required Experience:
Staff IC
Key Skills
- Laboratory Experience
- Vendor Management
- Design Controls
- C/C++
- FDA Regulations
- Intellectual Property Law
- ISO 13485
- Research Experience
- SolidWorks
- Research & Development
- Internet Of Things
- Product Development
About Company
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. Alongsid ... View more
