Quality Assurance Specialist - Marlborough, MA

IPG Photonics; Marlborough (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Attention to detail

Quality mindset

Multitasking

Interpersonal skills

Documentation-oriented

Education

High School Diploma or equivalent

Bachelor's degree in scientific/biomedical/engineering preferred

Tools

QMS

PLM

CMMS

MS Word

MS Excel

Job description

Are you looking for a rewarding career in manufacturing? If so, IPG Photonics may be the place for you! Working with IPG Photonics you can expect interesting tasks and challenging projects as well as a motivating and friendly environment. You will be working with teams that influence the future of laser technologies.

IPG Medical, a wholly owned subsidiary of IPG Photonics (NASDAQ: IPGP), is focused on developing next-generation products based on IPG Medical's state-of-the-art laser technology. Headquartered in Marlborough, MA, we aspire to work together with our employees and customers to apply light in ways that improve life.

Our mission is to develop innovative medical device laser solutions that make the world a better place. To accomplish this mission, we are committed to attracting and retaining the best talent and an engaged and thriving workforce that drives a sustainable future for our company and society.

Responsibilities:

• Review and approve incoming inspection reports as well as non-conforming material reports for conformity to specifications
• Support manufacturing operations through timely review ofDHR's including release of finished goods
• Adhere to good manufacturing practices and good documentation practices
• Participate in CAPA's to better improve company practices and systems
• Member of the Material Review Board of non-conforming material
• Train Quality Inspectors on good document practices, standard operating procedures and QC processes
• Assist in both internal and external audit preparation, support Quality management team during audits
• Promote awareness, visibility and communication relative to QMS goals and initiatives
• Other duties as assigned

Qualifications:

• High School Diploma or equivalent is required,Bachelor's degree in scientific, biomedical, or engineering discipline preferred
• 5-7 years of experience in Medical Device Quality Assurance required
• Solidunderstanding of ISO13485, ISO14644, andCFR 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 required for interaction within group and other departments
• Organizational skills and attention to detail
• Results-oriented, with ability to multitask
• Self-motivated and proactive