Quality Assurance Specialist - Device History Record (dhr)
Philips
Latham, NY, US
Base: $24.51 to $34.53 hourly; bonus/equity: annua...
5 day onsite
1+ years medical device experience
Proficiency in good documentation practices
Knowledge of iso 9001 and iso 13485
Philips is seeking a Quality Assurance Specialist for their Device History Record (DHR) team in Latham, NY. The role requires oversight of compliance with regulatory standards in the medical device manufacturing process, involving collaboration with various engineering and quality teams
Job Summary
This role ensures manufacturing records for medical device components are compliant with applicable standards before releasing product from the factory.
The position offers an opportunity to work closely with Quality, Manufacturing, and Design Engineers on a site leading innovation in MRI magnet design.
Employees are eligible for a comprehensive benefits program including generous PTO, a 401k match up to 7%, and stock purchase plans.
Matching Summary
Match Score: 85
Philips is seeking a Quality Assurance Specialist for their Device History Record (DHR) team in Latham, NY. The role requires oversight of compliance with regulatory standards in the medical device manufacturing process, involving collaboration with various engineering and quality teams.
Salary
Base: $24.51 to $34.53 Hourly; Bonus/Equity: Annual incentive bonus, sales commission, or long-term incentives may be offered; Benefits: Generous PTO, 401k match up to 7%, HSA, stock purchase plan, education reimbursement
Skills & Requirements
Must-have
1+ years medical device experience
Proficiency in Good Documentation Practices
Knowledge of ISO 9001 and ISO 13485
Understanding of FDA CRF 21 part 820
On-site work five days per week
Nice-to-have
Experience with eQMS Trackwise or EtQ
Experience with ERP SAP software
Collaboration with Quality Engineering teams
Background in MRI magnet design innovation
Key Requirements
Technical Diploma or Bachelor's Degree in engineering science
US work authorization required without sponsorship