Spectrum Plastics Group has an immediate opening for an experienced Quality Manager. The Minneapolis (St. Louis Park area) facility manufactures components for the medical, aerospace/defense and industrial markets. The facility is certified to ISO 13485, ISO 9001 and AS 9100, as well as being FDA registered. Internal processes include injection and insert molding, various secondary operations (stamping, ultrasonic welding, laser engraving, etc.), assembly, packaging, and machining of plastic components.
The ideal candidate will possess in-depth knowledge of quality assurance and quality control standards and methods associated with the manufacture of medical components. This position is accountable for managing, planning, organizing, directing, and controlling a Quality Assurance Program which includes quality control, quality engineering, regulatory compliance and product safety functions to ensure customer requirements are satisfied.
Strong leadership abilities
A thorough understanding of ISO 13485 and 21 CFR 820 (ISO 9001 and AS 9100 knowledge helpful)
Practical experience with SPC, capability analyses, MSA, DoE, FMEA, control plans, sampling methods
Well-versed in quality philosophies and can bridge the gap between theory and practical application
Bachelor of Science degree in quality, manufacturing, engineering or related discipline
At least three years of quality engineering experience and at least two years at the quality management level
Clean room manufacturing experience preferred
Innovative and creative thinker able to effectively apply process and risk management approaches and methods to continually enhance the effectiveness of the facility’s quality management system
Prefer ASQ certifications (CMQ/OE, CQE, and CBA or CQA)
Can effectively function independently and collaboratively
Expertise in facilitating problem-solving and continuous improvement efforts using proven methods and tools