Job Description

Job Description

Job Description

• 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)

• 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.

• BS in Engineering or Science
• 8 years relevant experience in a regulated environment (preferably medical device)
• 2 years directly supervising employees in quality

• 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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