H - Quality Engineer 1 RECRUITED - 18M014 - 100030
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H - Quality Engineer 1 RECRUITED - 18M014 - 100030
Ref No.: 14-01499
Location: Norwood, Massachusetts
Assist with implementation of the associated activities for the Quality Management System for Point of Care (POC) Business Unit. This includes Design Change and Process Verification and Validation, Author, review and approve design verification and validation plans, protocols and reports and participate in associated employee training.

Represent site for Document Change Control team, develop and implement improved processes for change control, design transfer. Interact with multiple functions and sites. This includes R&D, Engineering, Marketing, Validation Services, Clinical, Program Management, Regulatory, and Quality Compliance.

Assists in formulating associated quality policies, programs, plans, procedures, and practices. Performs routine statistical analysis as related to quality.

Specific responsibilities to include:

Develop and improve Verification and Validation process, forms and instructions to help streamline working practice
Develop logical and compliant sampling plans for validation activities
Work with OEM suppliers and CPE to ensure appropriate controls exist for proposed design changes.
Working knowledge of quality system requirements for medical device company with product development focus
Strong knowledge of requirements for QSR Verification and Validation.
Experience working in Quality System for medical devices.
Participate in and lead multifunctional teams