Design Quality Assurance Engineer

• 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.

• 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.

• 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.

Stryker