Quality Manager – ISO13485

Check out this amazing opportunity to work for a growing company located in Western, WI!

Company Information:
– This company has just over 100 employees in this 40,000 square foot facility, they are a part of a larger organization of 1,000 people at 9 locations!
– They have been in business 70 years, are continuously family owned, and are recognized for their family feel culture while offering plenty of growth opportunities.
– This company strives to be on the leading edge of technology by reinvesting in new and updated machinery and technology

This Company Values and Appreciates Their Employees:
– Medical
– Dental
– Vision
– Wellness programs
– 401k with 4% company match
– Company provided Life and Short Term disability insurance
– Paid Time Off and Holidays
– Bonus potential

Your Role with The Company:
– You will lead the Quality department consisting of 15-18 people and are responsible for department goals being achieved
– As the key point of contact, you be responsible for being the key role in ISO, FDA, and customer audits as well as coordinating the internal audits
– Being a member of the leadership team you will be involved in hiring and investments for the Quality department
– Being a key participant in the company’s LEAN initiatives, you will bring your knowledge and ideas into the team for overall company improvement
– Showcasing your expertise you will be a key role in the journey to taking the next step to higher FDA qualifications in pharmaceutical delivery

Background Profile
– 6 years of Quality Assurance experience with 2+ years people management experience
– Experience managing an ISO 13485 Quality Management system required
– Bachelor Degree in related field preferred or 4-10 years experience in related field required
– Solid experience in CAPA management (leading investigations) with expertise in root cause analysis preferred
– Experience in ISO Class 7 clean room environment preferred
– Injection molding & IQMS experience desired
– An excellent candidate will have a “process approach” mindset, with strong communication skills, impeccable attention to detail, and have a strong ability to work well with cross functional teams

Interested? Apply below! Inquiries can be sent to; referencing Job ID# mr3110.

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