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Senior Quality Engineer

Newton, MA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Senior Quality Engineer

Position Summary:

Will be responsible for implementation and maintenance of the organization's Supplier Quality process, while supporting the site’s overall Quality Management System (QMS). This position will be reporting to the Quality Manager at the Boston site.

Job Responsibilities:

• Lead the Supplier Quality process for Innovheart

• Ownership for quality performance and measurement including KPI’s and participate in supplier performance reviews.

• Enable reporting of metrics for management reviews.

• Lead quality issues with suppliers & partner with Internal Customers;

• Lead effective supplier containment and corrections/corrective actions

• Interface with vendors and communicate product design requirements and quality issues as needed.

• Develop Receiving Inspection operations, supplier survey/ audit responsibilities, and new product development operations.

• Lead Design for Manufacturing reviews between internal development team and external contract manufacturers.

• Act as a quality resource within internal design and development team.

• Review and approval of product and process verification and validation activities and measure readiness throughout the product development cycle including capability assessments and supplier qualifications.

• Provide engineering guidance to supplier incoming inspection processes including measurement techniques and statistical analysis

Knowledge, Education, Experience:

• Bachelor's Degree in Engineering required, with minimum 5 years of experience in Medical Device Quality

• Knowledgeable of regulatory requirements of Medical Devices, both US and EU.

• Strong verbal and written communication skills

• Must have experience with managing suppliers.

• Experience with Cardiac Catheters preferred.



55 Chapel St.

Newton, MA



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