Quality Assurance Manager

Sunlite Plastics

Sunlite Plastics is a custom extrusion company that specializes in high volume, tight tolerance, flexible medical tubing. We also compound PVC materials for our own use. Sunlite’s customers include many of the most highly regarded medical device OEMs in the world. We are looking for a Quality Assurance Manager to join our growing team.

What will you be doing?

As a key member of the site leadership team, the Quality Assurance Manager manages the enhancement, definition, execution, implementation, and maintenance of the Sunlite Plastics Quality Management System.

How will you do it?

• Leading and managing cross-functional teams to address and resolve quality issues and to improve our level of quality and productivity.
• Enhancing established quality/regulatory training for all departments.
• Analyzing Sunlite quality metrics and developing and implementing strategic initiatives to promote continual improvements.
• Managing all aspects of the documentation control system, including the review and approval of all Engineering Change Orders.
• Managing and executing corrective and preventive action programs.
• Reviewing and approving Risk Management activities.
• Acting as the Management Representative for ISO, customer, and regulatory agency audits.
• Administering REACH, EPA, DNR, RoHS, and other regulatory reporting programs.
• Evaluating the performance of the quality team and administering goals, metrics, merit increases, promotions, disciplinary actions, etc.

What qualifications and experiences will you be bringing to the team?

• Bachelor of Science Degree in technical discipline (engineering, science, or technical related). Experience in a production facility is required.
• Strong attention to detail and the ability to work with teams and handle multiple ongoing projects.
• Strong organizational skills.
• Computer proficiency in Microsoft Office.
• 5 years of experience in a quality environment. Experience within a regulated industry desired.
• Knowledge of ISO 9001 and/or ISO 13485.

What benefits will Sunlite provide to you?

• Medical, dental, and vision insurance
• Modern office space and work environment
• Paid vacation
• Matching 401K
• Paid holidays
• Flex spending account
• Health savings account
• Referral bonus program
• Employee assistance program

What physical demands would you be exposed to?

• You must be able to spot visual defects.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
• Frequently required to walk; use hands to finger, handle or feel; and reach with hands and arms.
• Occasionally required to stoop, kneel, or crouch.
• Must be able to lift up to 20 pounds and occasionally push, pull, or move over 20 pounds.