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:
As a Quality Engineer, you will play a key role in leading development activities, including supporting part validation, qualification, and sustaining programs.
– You will act as the primary contact for customer quality concerns and directly support the production and engineering departments in resolving these concerns.
– Participate in the overall Stage-Gate approach to product realization, managing APQP and PPAP activities for new and modified programs.
– Conduct Quality Planning: create Process Flow Diagrams, Process FMEA, and Process Control Plans. Prepare work instructions and inspection instructions.
– Oversee PPAP/validation for purchased materials and components, ensuring compliance and quality.
– Implement pre-launch and early containment activities while preparing necessary reports.
– Foster and enhance relationships with customers and suppliers through strong leadership and direct engagement.
– Make decisions on materials placed on hold within the company.
– Participate in creating and managing CAPAs, SCARs, RMA activities, and sustaining programs.
– Write and issue Quality Alerts as needed.
– Develop and perform validation protocols.
– Collaborate with customers and employees to provide consultation on quality issues and conduct training related to the Quality Management System.
– This position reports to the Quality Manager and will interact with many functions of the company so your success will be recognized!

Background Profile:
– 4+ years of experience in quality engineering, specifically within an ISO 13485-certified or highly regulated manufacturing environment.
– Experience with APQP, PPAP, IQ, OQ, PQ, and SPC.
– Knowledge of ISO 9001, ISO 13485, or FDA regulations.
– Strong capabilities in print reading, cGMP/GDP, GD&T, and cosmetic specifications are advantageous.
– Proven ability to manage multiple projects
– Ability to manage time while juggling multiple responsibilities.
– Understanding of injection molding processes preferred.
– Excellent communication and interpersonal skills to build positive relationships with internal and external customers.
– A Bachelor’s degree in a relevant field is a plus.

Interested? Inquiries can be sent to jen@connect-ology.com, please reference Job ID# mr3364.