Senior Quality Engineer

Essential Functions

• Assisting with Customer Audits, Internal Audits, Notified Body Audits, and FDA Inspections
• Assisting with Supplier Management (including but not limited to supplier performance review, and supplier audits)
• Managing Direct Reports
• Developing and implementing quality control procedures and guidelines
• Monitoring and analyzing data to identify areas for improvement
• Initiating quality improvement projects
• Collaborating with cross-functional teams to resolve quality issues
• Conducting audits on products and processes
• Providing guidance to other team members
• Investigating and resolving customer complaints
• Conforming to ISO13485, 21 CFR Part 820, and medical device industry requirements
• Reviewing and approving product and process changes
• Developing procedures and work instructions as needed
• Other work-related tasks as assigned

Competencies

• Strong background in quality control and quality engineering functions
• Understanding GD&T
• Experience with Statistical Software
• Experience with Gage Repeatability and Reproducibility
• Excellent communication skills
• Excellent leadership skills
• Detail-oriented
• Strong analytical and problem-solving skills
• Able to manage multiple projects simultaneously
• Strong understanding of medical device regulations

Education Requirements

• B.S. in Engineering field preferred or minimum of 5 years in Quality Engineering role
• Experience 5-7 years of Medical Device experience in Quality setting preferred