Quality Assurance Specialist

IPG Photonics • Marlborough, MA

21d

About The Position

IPG Medical, a wholly owned subsidiary of IPG Photonics, develops next-generation products using its laser technology. The Quality Assurance Specialist supports medical-device manufacturing quality operations, product release, quality systems, and audit activities. The role works with manufacturing and quality teams to uphold applicable standards, documentation practices, and quality management system goals.

Requirements

• High school diploma or equivalent.
• Five to seven years of experience in Medical Device Quality Assurance.
• Solid understanding of ISO 13485, ISO 14644, and CFR 21-820.
• Prior experience working in a clean room.
• User experience with QMS, PLM, and CMMS systems.
• Strong working knowledge of Microsoft Word and Excel.
• Strong oral, written, and interpersonal skills for interaction within the group and with other departments.
• Organizational skills and attention to detail.
• Results-oriented, with the ability to multitask.
• Self-motivated and proactive.

Nice To Haves

• Bachelor's degree in a scientific, biomedical, or engineering discipline.

Responsibilities

• Review and approve incoming inspection reports and non-conforming material reports for conformity to specifications.
• Support manufacturing operations through timely review of device history records (DHRs), including release of finished goods.
• Adhere to good manufacturing practices and good documentation practices.
• Participate in corrective and preventive actions (CAPAs) to improve company practices and systems.
• Serve as a member of the Material Review Board for non-conforming material.
• Train Quality Inspectors on good documentation practices, standard operating procedures, and quality control processes.
• Assist with internal and external audit preparation and support the Quality management team during audits.
• Promote awareness, visibility, and communication regarding quality management system goals and initiatives.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED