Quality Manager (ISO 13485)

Privately held, growing, and well respected in the thin gauge thermoforming packaging industry is seeking a Quality Manager for their manufacturing plant in the Midwest region of the US. You will lead the Quality Team and all quality efforts for the manufacturing plant, working in partnership with the leadership team. Having the requisite experience and career path in manufacturing Quality is assumed, including several years in leadership roles. The Quality Team is made up of shift-focused Quality Techs, Quality Engineers, Quality Specialists, with a total of 12-15 team members. Must have experience in manufacturing medical devices and/or packaging .

ISO 13485

knowledge is imperative. Understanding validations, PPAP, IQ/OQ/PQ is all part of this role. Prefer someone with an engineering background as technical writing and reporting is an important aspect of the role given the higher regulatory requirements. Training and development experience is critical . There is a lot of growth at this plant and therefore several new Quality Techs on off-shifts that are struggling. Strong abilities in statistics and SPC would also be a high want.

Location:

This is currently a confidential search, so the best we can provide is a Midwestern US onsite location.