Senior Quality Manager - Medical Device - IPG Photonics
Marlborough, MA 01752
About the Job
Thank you for your interest in positions at IPG Medical Group. All applicants must apply on our company website to be considered. Please visit www.ipgphotonics.com and click on the “Company” tab. We look forward to seeing your application soon!
IPG Medical Corporation is focused on developing next-generation medical products based on its state-of-the-art technology. The Senior Quality Assurance Manager is responsible for maintenance and continuing improvement of the quality management system (QMS) and compliance with all applicable regulations and standards for medical devices.
IPG Medical Corporation is focused on developing next-generation medical products based on its state-of-the-art technology. The Senior Quality Assurance Manager is responsible for maintenance and continuing improvement of the quality management system (QMS) and compliance with all applicable regulations and standards for medical devices.
Responsibilities and Duties:
- Responsible, under general direction of Senior Management, for reviewing, improving and maintaining most aspects of the quality system including the Quality Manual and procedures/processes, including document and data control, quality planning, training, vendor approval / monitoring, equipment calibration, complaint handling and trending, product recalls / advisory notices, corrective and preventive action system, internal quality audits, non-conforming materials, incoming and final inspection.
- Manage Quality Engineers, Specialists, and Inspectors by providing direction, mentorship, and growth opportunities.
- Reporting on the performance of the quality management and proposing recommendations to improve the system to Senior Management
- Support, as needed, regulatory assurance, engineering and Senior Management with regulatory filings, creation of technical files, vigilance / incident reports, internal and external audits, and sign-off for relevant documents.
- Conduct product design control activities for new and sustaining product development efforts.
- Support risk analysis activities, including design and process FMEA.
- Support Process/Design Validation/Verification activities, including software validation and IQ/OQ/PQ activities.
- Support Manufacturing Engineering in the creation of DMR, DHR, routers, bills of material, and specifications for in- house / external manufacturing.
- Conduct Internal Audits of the Quality System
- Prepare for and participate in audits by external organizations, such as FDA, Notified Bodies etc.
- Perform all other essential duties as assigned.
Experience and Education Desired:
- 10-15 years of experience in Medical Device Quality Assurance, with a minimum of 5 years of hands-on management experience is required.
- Bachelor’s degree in scientific, biomedical, or engineering discipline required.
- Solid understanding of applicable regulations, including FDA 21 CFR Part 820, ISO 13485, Health Canada MDD’s, European MDR’s.
Competencies: (soft skills)
- Self-motivated and proactive, with consistent ability to follow-through on projects
- Impeccable attention to detail
- Strong oral, written and interpersonal skills required for interaction within the organization and external customers.
- Hands-on and results-oriented, with ability to multitask.
- Ability to maintain professional demeanor at all times.
This position must meet Export Control compliance requirements, therefore a “US Person” as defined by 22C.F.R. §120.15 are required. “US Person” includes US Citizen, lawful permanent resident, refugee, asylee. License exception Technology and software under restriction (TSR) defined in 15 CFR 740.6 may permit person from Country Group B.
The following link will take you to the government site with the list of Country Group B: https://www.bis.doc.gov/index.php/documents/regulation-docs/452-supplement-no-1-to-part-740-country-groups/file.
Equal Opportunity Employer / Affirmative Action M/F D/V
Equal Opportunity Employer / Affirmative Action M/F D/V
IPG Photonics Corporation is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. All employment decisions and personnel actions at IPG Photonics are administered without regard to race, color, religion, creed, national origin, ancestry, sex, age, qualified mental or physical disability, gender identity, sexual orientation, genetic carrier status, any veteran status, any military service, any application for any military service, or any other category or class protected by applicable federal, state or local laws. IPG Photonics Corporation provides reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974 and Title I of the Americans with Disabilities Act of 1990. Applicants who need accommodation in the job application process should contact (508) 506-2527 or email HR.Accommodations@ipgphotonics.com to request assistance. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.
Source : IPG Photonics