Quality Manager

4 weeks ago

St Paul, United States Connectology Full time

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 jen@connect-ology.com, please reference Job ID# mr3338.

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