Senior Quality Engineer

Responsibilities

• Works with Product Development and Operations teams to establish quality requirements at all phases of product/process development and manufacturing.
• Work with Product Development on product V&V activities including sterilization, packaging/labeling, transit testing, real time/accelerated aging as well as creation of protocols and reports.
• Work with Product Development on the Risk Management Process and maintains the Risk Management File.
• Responsible for the Design History File, device Master Record and its maintenance.
• Responsible for setting up the receiving inspection area, perform materials inspection such as incoming, First Article Inspection, and final product release.
• Responsible for documenting product discrepancies and follow up on NC implementation and closure.
• Responsible for all supplier management activities including sourcing and qualifying suppliers, maintaining the Approved Suppliers List (ASL) and associated files, and managing the Supplier Corrective Action Request (SCAR) program.
• Responsible for CAPA management from CAPA generation to implementation of corrective action, verification of effectiveness, and closure.
• Affords assistance with internal audits. Assists with hosting external audits and drive all issues to closure if need be.
• Responsible for product packaging/labeling and ensuring all materials are conforming with applicable regulations.
• Other duties as assigned.

Qualifications

• BS degree in Engineering, life sciences or related field – Advanced degree preferred.
• 5 plus years experience as a Quality Engineer or in related field in the medical device Industry. ASQ CQE is a plus.
• Experience with design control is a must.
• Experience with software and firmware V&V is strongly preferred.
• Applies regulatory requirements such QSR, MDR, ISO and generate procedures in compliance with regulations
• Excellent people skills, team oriented
• Excellent problem-solving skills
• Effective written and verbal communication and organizational skills
• Be able to coach others or teach the proper use of quality tools and problem solving techniques.

Benefits

Competitive compensation and an excellent company-paid benefits package.