Medical Device QA Specialist – ISO 13485

IPG Laser GmbH; Marlborough (MA); In loco; USD 31.000 - 36.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health Insurance

401(k) Match

Paid Vacation

Tuition Reimbursement

ESPP

Descrizione del lavoro

IPG Photonics’ Marlborough, MA site seeks a Quality Assurance professional to drive compliance and process improvements in medical device manufacturing. You will review reports, support release of finished goods, and train QA staff while ensuring GMP and QMS standards are met.

Ideal candidates hold a science/engineering degree with 5–7 years of QA in medical devices, familiarity with ISO13485, CFR 21-820, and clean room operations. Strong communication and multitasking abilities are essential.

Competenze

• Bachelor's degree in scientific, biomedical, or engineering discipline preferred.
• 5-7 years of experience in Medical Device Quality Assurance required.
• Solid understanding of ISO13485, ISO14644, and CFR 21-820.
• Prior experience working in a clean room.
• User experience of QMS, PLM and CMMS systems.
• Strong working knowledge of Microsoft Word and Excel.
• Strong oral, written and interpersonal skills; organized and detail oriented.
• Results-oriented with ability to multitask; self-motivated and proactive.

Mansioni

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

Conoscenze

Medical Device QA

ISO13485

Clean Room

QMS Systems

PLM

CMMS

MS Word & Excel

Communication Skills

Organizational Skills

Multitasking

Self-motivated

Formazione

Bachelor's degree in science/engineering

High School Diploma or equivalent

Strumenti

QMS Software

PLM

CMMS

Microsoft Word

Microsoft Excel

Descrizione del lavoro

IPG Photonics’ Marlborough, MA site seeks a Quality Assurance professional to drive compliance and process improvements in medical device manufacturing. You will review reports, support release of finished goods, and train QA staff while ensuring GMP and QMS standards are met.

Ideal candidates hold a science/engineering degree with 5–7 years of QA in medical devices, familiarity with ISO13485, CFR 21-820, and clean room operations. Strong communication and multitasking abilities are essential.