The Quality Engineer 3 will report to the Sr. Manager of Quality in Walpole facility. The Quality Engineer is responsible for a wide variety of activities to ensure compliance with applicable regulatory requirements, such as documentation reviews, conducting quality assessments, material investigation report reviews, and data analysis. Consults and work collaboratively with all business areas. Help identify discrepancies and work to obtain resolution of the discrepancies with the responsible individual(s). Prepare and update Quality Assurance documents to ensure conformance with the regulations and guidelines. Desired Skills and Experience:

• 2 to 4 years of successful work experience in quality discipline or related field in the medical device or biotechnology industry
• BS in an Engineering or Life Sciences field preferred with successful demonstration of key responsibilities and job knowledge
• Knowledge of FDA Quality System Regulation (QSR); ISO 13485; ISO 14971
• Experience participating in multifunctional teams
• Competent with Microsoft Office suite (Excel, Word, Outlook, etc.)
• Possess an attention to detail
• Must have the ability to interact professionally and positively with cross functional team members.

Ideal candidate:

• Working knowledge of quality system requirements for a medical device company
• Successful work experience of 2 to 4 years in Quality field
• ISO 13485 quality system experience
• Exposure with FDA and/or notified body audits