Medical Device QA Specialist – ISO/GMP Excellence

IPG Photonics; Marlborough (MA); Presencial; USD 90 000 - 120 000; Tempo integral

Resumo da oferta

IPG Medical, a subsidiary of IPG Photonics, Marlborough, MA, is seeking a Quality Assurance professional to review and approve inspection reports, support manufacturing through DHRs, and uphold GMP and documentation practices.

The role requires 5–7 years of Medical Device QA experience, strong knowledge of ISO13485, ISO14644, CFR 21-820, and hands-on use of QMS, PLM and CMMS systems. Clean room experience and strong communication are essential.

Qualificações

• Requires 5–7 years of experience in Medical Device Quality Assurance.
• Solid understanding of ISO13485, ISO14644, and CFR 21-820.
• Prior experience in a clean room environment.
• Experience with QMS, PLM and CMMS systems.
• Proficient in Microsoft Word and Excel.
• Strong verbal and written interpersonal skills; detail-oriented.

Responsabilidades

• Review and approve incoming inspection reports and non-conforming material reports per specifications.
• Support manufacturing operations through timely review of DHRs including release of finished goods.
• Adhere to GMP and good documentation practices.
• Participate in CAPAs to improve practices and systems.
• Be a member of the Material Review Board for non-conforming material.
• Train Quality Inspectors on documentation practices, SOPs and QC processes.
• Assist in internal and external audit preparation; support QA during audits.
• Promote awareness of QMS goals and initiatives.

Conhecimentos

Attention to detail

Quality mindset

Multitasking

Interpersonal skills

Documentation-oriented

Formação académica

High School Diploma or equivalent

Bachelor's degree in scientific/biomedical/engineering preferred

Ferramentas

QMS

PLM

CMMS

MS Word

MS Excel

Descrição da oferta de emprego

IPG Medical, a subsidiary of IPG Photonics, Marlborough, MA, is seeking a Quality Assurance professional to review and approve inspection reports, support manufacturing through DHRs, and uphold GMP and documentation practices.

The role requires 5–7 years of Medical Device QA experience, strong knowledge of ISO13485, ISO14644, CFR 21-820, and hands-on use of QMS, PLM and CMMS systems. Clean room experience and strong communication are essential.