Senior Quality Engineer

CTE Solutions•Plymouth, IN

15d•Onsite

About The Position

At SpiTrex CTE, we invest in our people. You’ll find opportunities to grow, real flexibility, and a culture that values balance, development, and teamwork. Ready to grow with a company that values you? Join SpiTrex CTE.

Requirements

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

Responsibilities

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