Design Quality Assurance Engineer
Design Quality Assurance Engineer
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Job Description
Position Summary
Due to expansion in Lund Stryker is recruiting for a new Design Quality Assurance Engineer to add the team. This person will partner with cross-functional project teams in New Product Development (NPD) and Engineering Projects during the product development and change control processes to drive quality assurance. Lead risk management activities to ensure the highest level of product and process quality.
Key Responsibilities
- Develop quality assurance documentation to support new product development process sustaining engineering activities and regulatory submissions.
- Partner with cross-functional project teams to lead product and/or process design and development and change activities.
- Lead risk management activities for new product development projects and engineering changes.
- Evaluate overall residual risk for products prior to launch and present final risk/benefit justification to executive leadership.
- Present risks associated with the product use and track how the design documentation and manufacturing process mitigate those issues throughout the development process.
- Partner with cross-functional project teams to define design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria.
- Utilize standard statistical analysis and problem-solving techniques to determine product acceptance limits resolve quality problems etc.
- Contribute to the completion of final design verification and validation reports.
- Develop review and approve documents as needed.
- Support product design transfers to internal and/or external partners
- Engage in quality system maintenance by identifying and correcting deficiencies in procedures and practices.
- Provide support and direction for other Quality Engineers.
- Analyze and define critical quality attributes for product through risk analysis techniques.
- Participate in collection of initial market feedback on new products and address early concerns.
Minimum qualifications
- BS in a science engineering or related discipline. MS preferred.
- 4 years work experience in relevant field.
- Good written and verbal communication skills in English and Swedish.
Preferred qualifications
- Experience with medical device product development lifecycle including risk management and design/process verification and validation and associated standards.
- Experience in interacting with regulatory agencies (FDA MoH Notified Bodies etc.) required.
- Thorough knowledge and understanding of US and Global Medical Device Regulations.
- Strong knowledge of Quality Concepts (e.g. CAPA Audits Statistics).
- Must possess strong project management skills as well as have the ability to manage multiple tasks simultaneously.
- Demonstrated ability to advocate for product excellence and quality.
- Demonstrated ability to effectively work cross-functionally with other departments including Product Development Regulatory Affairs and Marketing.
The Company
Jolife AB a wholly owned company by Stryker Inc develops and markets the LUCAS Chest Compression System with related accessories for the global market. LUCAS is a Swedish breakthrough innovation for mechanical chest compressions used during cardiopulmonary resuscitation (CPR).
Travel Percentage: 10%Employment Type
Full-Time
