IPG Photonics
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IPG Medical Corporation is focused on developing next-generation medical products based on its state-of-the-art technology. The Quality Engineering Manager is responsible for managing the quality engineering activities for transfer to manufacturing and sustaining manufacturing in compliance with all applicable regulations and standards for medical devices.
SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES:
- Provide manufacturing quality engineering leadership to manufacturing and sustaining engineering.
- Manage direct reports by providing direction, mentorship and growth opportunities
- Report on the Manufacturing and Quality KPIs
- Conduct product design control activities for new and sustaining product development efforts
- Support risk analysis activities, including design and process FMEA
- Participate in quality driven supply chain activities.
- Participate in the reliability / customer complaint team meetings.
- 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
- Prepare for and participate in internal and external audits with notified bodies and customers
- Perform other duties as assigned to support the advancement of the QMS and product manufacturing.
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Requirements
experience/QUALIFICATIONS:
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- Minimum of a bachelor’s degree in science, engineering, or other related technical discipline and 5 – 10 years of medical device experience or 10-15 years of experience in medical device quality engineering.
- Solid understanding of medical device ISO 13485, FDA 21 CFR 820.
- Familiar with MDR (EU) 2017/745/MDD, ISO 14971
- Experience with intravascular catheters and/or electro-mechanical hardware.
- Medical device software experience a plus.
- Experience with sterile product preferred.
- Able to effectively manage workload and deliverables.
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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
- Paid sick time
- 12 (twelve) Paid Holidays Each Calendar Year
- 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
- Parental Bonding Leave
- Bright Horizons Backup Care
- Bright Horizons College Coach
*Prorated for reduced hour schedules
Additional Benefits Offered: IPG also offers access to:
*Benefits eligibility may differ by program for reduced hour schedules
Deadline and How to Apply
This job posting will remain active until a candidate is identified and/or the Company rescinds the job posting.
For full consideration, please click on the link to apply.
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“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 [email protected] opens an email client applicationto request assistance. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.
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