Quality Assurance Manager
1 month ago
We are searching for a Quality Assurance Manager for a medical device manufacturing client in Milwaukee, WI. As an integral part of the site leadership team, the Quality Assurance Manager oversees the improvement, definition, execution, implementation, and upkeep of the Quality Management System.
Requirements of the Quality Assurance Manager:
- Bachelor of Science Degree in a 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.
- Experience managing direct reports
- 5+ years of experience in a quality environment. Experience within a regulated industry or medical device desired.
- Knowledge of ISO 9001 and/or ISO 13485
Responsibilities of the Quality Assurance Manager:
- Manage the enhancement, definition, execution, implementation, and maintenance of the Quality Management System.
- Lead and manage cross-functional teams to address and resolve quality issues and improve level of quality and productivity.
- Enhance established quality/regulatory training for all departments.
- Analyze quality metrics and develop and implement strategic initiatives to promote continual improvements.
- Manage all aspects of the documentation control system, including the review and approval of all Engineering Change Orders.
- Manage and execute corrective and preventive action programs.
- Review and approve Risk Management activities.
- Act as the Management Representative for ISO, customer, and regulatory agency audits.
- Administer REACH, EPA, DNR, RoHS, and other regulatory reporting programs.
- Evaluate the performance of the quality team and administer goals, metrics, merit increases, promotions, disciplinary actions, etc.
Occupational Category: 17-2112.03 (Manufacturing Engineers)
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