Senior Quality Assurance Engineer
4 weeks ago
Custom Search is seeking a highly skilled Sr. Design Assurance Engineer to join our team. As a key member of our medical device development project teams, you will be responsible for ensuring compliance to Design Controls requirements. Your expertise in quality activities and deliverables will drive consistent quality engineering practices among our team members.
Key Responsibilities:
• Lead design verification, design validation, usability and test methods validation activities for new product development to meet or exceed internal and external requirements.
• Champion departmental or cross-functional engineering initiatives and act as an effective leader or team member in supporting quality disciplines, decisions and practices.
• Partner with Regulatory development project team members to summarize or generate information to be supplied to Regulatory Agencies.
• Utilize problem solving methodologies to lead failure investigation activities to ensure root cause is identified and proper controls are established.
Requirements:
• 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.).
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