Quality Manager – ISO 13485

Website Connectology

Leverage your quality leadership and ISO13485 experience for an industry-leading company in the Twin Cities Metro!

Company Information:
– A leader in their industry with 50 years in business
– ISO 13485 certified
– FDA and ITAR registered
– 100+ employees
– Privately held
– A place for people who care about their work and co-workers and know how to have FUN!

This Company Values and Appreciates Their Employees:
– Merit-based compensation, Recognition gifts, and Performance awards
– Medical, Dental, and Vision insurance
– 401k with company match
– Paid time off and holidays
– Company-sponsored events and more!

Your Role with The Company:
– Overseeing the maintenance of ISO 9001, and 13485 Quality Management System
– Assuring that all documents, standard requirements, and defined processes comply with standards
– Acting as the ISO and 13485, and FDA Regulatory Management Representative
– Leading weekly quality meetings to address scrap, rework, and returns and facilitating improvements needed to prevent future issues
– Addressing customer requirements and working to correct customer issues as they arise
– Guiding the team on PPAP and APQP processes to ensure seamless product launches
– This position reports to the General Manager and will interact with many functions of the company so your success will be recognized!

Background Profile:
– 5+ years of demonstrably successful experience in quality management or senior-level quality engineering, specifically within an ISO 13485-certified medical device manufacturing environment.
– Deep understanding of injection molding processes, including troubleshooting, risk mitigation, and process optimization methodologies preferred.
– Proven ability to implement and maintain robust quality management systems, ensuring compliance with relevant regulations and standards.
– Strong leadership skills with the ability to motivate, guide, and mentor teams. Proven ability to collaborate effectively across departments and influence stakeholders.
– Adept at utilizing statistical tools like DOE, Cp/CPK, Gauge R&R, FEMA, SPC, and PPAP to analyze data, identify root causes, and optimize processes.
– Proficiency in Lean or Six Sigma methodologies for continuous improvement desired.
– Strong influential leadership skills, proven ability to influence cross-functionally
– Excellent communication and interpersonal skills to build positive relationships with customers and represent the company professionally.
– Ability to understand and troubleshoot customer issues related to medical injection molded products.
– A Bachelor’s degree in a relevant field (e.g., Engineering, Science, Quality Management) is a plus.

Interested? Inquiries can be sent to, please reference Job ID# mr3338.

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