Overview
On Site
USD 140,000.00 - 160,000.00 per year
Contract - Independent
Skills
Mergers and Acquisitions
Regulatory Compliance
Leadership
Mentorship
Reporting
KPI
Product Design
Product Development
Risk Analysis
FMEA
Supply Chain Management
Process Modeling
Verification And Validation
IQ
OQ
PQ
Manufacturing Engineering
DMR
Routers
Bill Of Materials
Auditing
QMS
Manufacturing
Science
Quality Assurance
ISO 13485
ISO 9000
Mechanical Engineering
Computer Hardware
Medical Devices
Management
Privacy
Marketing
Job Details
Location: Marlborough, MA
Salary: $140,000.00 USD Annually - $160,000.00 USD Annually
Description: Our client is currently seeking a Quality Engineering Manager who will be 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.
Job Function:
Job Requirement:
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.
By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.
Contact:
This job and many more are available through The Judge Group. Please apply with us today!
Salary: $140,000.00 USD Annually - $160,000.00 USD Annually
Description: Our client is currently seeking a Quality Engineering Manager who will be 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.
Job Function:
- 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.
Job Requirement:
- 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.
By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.
Contact:
This job and many more are available through The Judge Group. Please apply with us today!
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