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Our mid-sized medical device client is adding a Sr. Design Assurance Engineer to the team! The Sr. Design Assurance Engineer utilizes risk management and quality planning activities to provide quality engineering support of product/process development and input to Quality Management Systems affecting product/process development. Champions departmental or cross-functional engineering initiatives and acts as an effective leader or team member in supporting quality disciplines, decisions and practices.
Your role with the company:
- Key member of medical device development project teams to ensure compliance to Design Controls requirements.
- Responsible for quality activities and deliverables on the cross-functional development team.
- Responsible for strategic quality planning activities on the project, including PMS planning.
- Assures that proper controls are established to meet or exceed internal and external requirements.
- Cross-functional leader for completion of Risk Management deliverables.
- Partners with Regulatory development project team members to summarize or generate information to be supplied to Regulatory Agencies
- Utilizes problem solving methodologies to lead failure investigation activities to ensure root cause is identified and proper controls are established.
- Leads design verification, design validation, usability and test methods validation activities for new product development to meet or exceed internal and external requirements.
- Coaches and mentors product development team on Design Control activities.
- Drives consistent quality engineering practices among DA team members
- Responsible for impact assessment and integration of Quality System changes into project execution.
- Ensures quality system compliance and primary team contact for audits. Surfaces Quality System issues/gaps to appropriate organization level.
Desired Profile:
- BS or advanced degree in engineering or related discipline
- 5+ years overall medical device experience
- 5+ years experience in quality assurance or engineering function
- Expert knowledge of Design Control and Risk Management
- Knowledge of Problem Solving methodologies and approaches
- Experience with Quality Systems as outlined in CFR820/ ISO13485
- Experience with leading CAPA investigations and developing effective corrective actions that utilize a risk based approach
- Demonstrated technical expertise and leadership in quality
- Strong ability to communicate (written and verbally) within and across disciplines and organizational structures
- Demonstrated use of Quality tools and methodologies
- Practical knowledge of applied statistics, including statistical analysis tools (Minitab, JMP, etc.)
- High attention to detail, organization and accuracy
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