Quality Assurance Manager
3 months ago
- Looking for ISO 13485 + FDA 21 CFR part 820 experience
- Must be a great collaborator with strong communication skills
- Switching to Greenlight Guru EQMS. A plus to have experience with this or Oracle
- Need help with process improvement
- Engineering degree or experience highly preferred
- Would manage team of 4 (2 FTE’s and 2 contractors)
Responsibilities:
- Manage the Quality Affairs team
- Develop/improve/maintain processes and procedures to ensure the most robust product designs and product quality is consistently manufactured.
- Ensure timely and robust incoming inspection; partner with suppliers to drive quality improvements.
- Develop strong partnerships with R&D, manufacturing, marketing, sales and regulatory.
- Ensure compliance with applicable FDA and ISO requirements.
Qualifications:
- BS in Engineering or Science
- 8 years relevant experience in a regulated environment (preferably medical device)
- 2 years directly supervising employees in quality
Desired Knowledge, Skills, and Abilities:
- Good problem-solving, critical thinking skills
- Strong written and verbal communication
- Sense of urgency
- Continuous improvement
- Leadership presence
- Oracle experience is a plus
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