Staff NPD Quality Engineer

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Job Function
Quality
Job Sub Function
R&D/Scientific Quality
Job Category
Professional
All Job Posting Locations:
Raynham, Massachusetts, United States of America
Job Description
The Staff New Product Development (NPD) Quality Engineer provides Quality Engineering leadership on new product development projects in the areas of Design Controls and Design Transfer to Manufacturing including, but not limited to:
Risk Management, Design Verification and Validation Strategies, and Design Transfer to Manufacturing. The Staff engineer operates at a high level of independence and has strong competency with problem solving and escalation pathways. This role is for our Joint Reconstruction organization supporting our Shoulder Reconstruction portfolio of products.
Duties & Responsibilities
The Staff NPD quality engineer will be responsible for the following, but not limited to:

• Serve as lead quality engineer on cross functional new product development projects.
• Leads design transfer activities with internal and external (suppliers) stakeholders.
• Leverage technical competency in key core competency areas including but not limited to statistical techniques, GD&T, inspection methodologies, and process validations to support new product introduction.
• Leads root cause investigations using various problem solving techniques and tools.
• Provide leadership in all areas of the Quality System, including, but not limited to corrective & preventive actions, product complaints, post market surveillance, nonconformances, risk management, and audits.
• Provide leadership in the understanding of medical device regulations to other disciplines.
• Communicates effectively at all levels within Quality, as well as cross functionally with departments such as Product Development, Regulatory, Supply Chain, and Marketing.
• Mentors others in various technical capabilities.

Additional Duties
Responsible for communicating business-related issues or opportunities to next management level
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Experience And Education

• Bachelor’s degree in Engineering or related technical/scientific field AND 6 or more years related experience.
• Understanding of new product introduction processes, and expertise in process qualifications/validations.
• Strong knowledge of GD&T and inspection methodologies.
• Experience implementing appropriate risk mitigation with knowledge of product and process Risk Management (FDA & ISO standards).
• Advanced knowledge of Quality Engineering/Scientific Method techniques and principles.
• Demonstrates a strong understanding of all areas of the Quality System, including, but not limited to corrective & preventive actions, product complaints, post market surveillance, nonconformances, risk management, and audit.
• Familiarity with manufacturing processes and controls.
• Experience with technical mentorship or managing co-ops/contractors preferred.

REQUIRED KNOWLEDGE,…