Quality Assurance Specialist

IPG Laser GmbH; Marlborough (MA); On-site; USD 31,000 - 36,000; Full time

Benefits offered by this job

Health Insurance

401(k) Match

Paid Vacation

Tuition Reimbursement

ESPP

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Medical Device QA

ISO13485

Clean Room

QMS Systems

PLM

CMMS

MS Word & Excel

Communication Skills

Organizational Skills

Multitasking

Self-motivated

Education

Bachelor's degree in science/engineering

High School Diploma or equivalent

Tools

QMS Software

PLM

CMMS

Microsoft Word

Microsoft Excel

Job description

Marlborough, Massachusetts, United States

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

Requirements

* 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

Location(s)

225 Cedar Hill Street, Marlborough , Massachusetts 01752 , United States

Employment Type

Non-Exempt

Wage Information

MA: $22.54 - $26.21

US Benefits Information

Pay Range:

The pay range on this posting applies to the role in the primary location specified. If the candidate would ultimately work outside of the primary location posted, the applicable range could differ. Actual starting pay is determined by a number of factors including relevant skills, qualifications, and experience.

Other Compensation: Employees in this role are eligible for additional rewards which could include:

• Annual Discretionary Bonus or Sales Bonus as Applicable

Benefits Provided: All Regular* US employees receive:

• Paid vacation time accrued based on years of service

*Prorated for reduced hour schedules

Additional Benefits Offered: IPG also offers access to:

• Medical, dental, and vision insurance plans with options for HSA/FSA
• Dependent Care FSA
• Paid Basic Life and AD&D Insurance
• Short-term and Long-term Disabilityinsurance
• 401(k) plan with Company matching
• Employee Stock Purchase Plan (ESPP)
• Tuition Reimbursement Program
• Employee Assistance Program (EAP)
• Adoption Assistance
• Pet Insurance
• Bright Horizons Backup Care
• Bright Horizons College Coach

*Benefits eligibility may differ by program for reduced hour schedules

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