Job Summary :
Seeking a Senior Quality Engineer with experience in process validation and risk management for the Structural Heart division, focusing on Class III medical devices.
Job Requirements :
- BS in Engineering
- 5+ years of Quality Assurance experience in a QSR (GMP), disposable medical device environment
- Experience in process validation procedures in accordance with QSR, FDA, and international guidelines
- Experience in performing risk assessment activities and mitigating product quality or compliance risks
- Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93 / 42 EEC), JPAL, and ISO 13485 : 2003
Preferred Skills :
- ASQ certification
- Six-Sigma Greenbelt or Blackbelt certification
- Experience in a team environment
- Effective verbal and written communication, analytical, influencing, and interpersonal skills
- Experience with Class III medical devices, particularly in the Structural Heart field
Job Responsibilities :
- Assist with writing and executing process validation procedures according to regulatory guidelines
- Perform risk assessment activities to identify and mitigate product quality or compliance risks
- Collaborate with engineering and manufacturing functions to ensure quality standards are maintained
- Participate in developing and maintaining quality plans and inspection systems for components, assemblies, and finished products
- Provide comprehensive support in pre-production component development and production-ready component and finished device manufacturing
Pay Details : $40.00 to $60.00 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan.
Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs.
In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer / Veterans / Disabled
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