Design Quality Assurance Engineer

Stryker Group; Lunds kommun; On-site; SEK 500 000 - 700 000; Full time

Job summary

A global medical device company in Lund is seeking a Design Quality Assurance Engineer to support new product development initiatives. The role involves developing quality assurance documentation, leading risk management activities, and collaborating with cross-functional teams to ensure optimal product quality. Candidates should have a BS in a relevant field and at least 4 years of experience, along with proficiency in English and Swedish.

Qualifications

• 4+ years work experience in relevant field.
• Experience with medical device product development lifecycle.
• Knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).

Responsibilities

• Develop quality assurance documentation for new product development.
• Lead risk management activities for new product development projects.
• Define design verification and validation test requirements.

Skills

Communication skills in English

Communication skills in Swedish

Education

BS in a science, engineering or related discipline

MS preferred

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).