1st Shift: Monday to Thursday, 6AM - 3PM; Friday, 6AM - 10AM
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
- Initiate quality improvement projects
- Collaborate 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
- Conform 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
Competency:
- 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
- Ability to manage multiple projects simultaneously
- Strong understanding of medical device regulations
Educational 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
Benefits Include:
- Medical, Vision and Dental Insurance
- Short-Term Disability
- Life Insurance
- 401(k) - 50% company match (up to 10% contribution)
- Paid vacation days
- Paid holidays
