- The QA Leader position reports to the Director of Operations and is responsible for driving the overall Quality Management System (QMS), and strategic and tactical quality performance for both facilities. This includes effective problem solving, root cause analysis with corrective action implementations and appropriate countermeasures with a Lean Manufacturing and PDCA (Plan-Do-Check-Act) methodology. This position will have a presence in the Oakdale and Blaine, MN facilities.
- Manage the QMS and quality staff for both facilities in Oakdale and Blaine MN
- Leads all customer complaint investigations and is the CAPA subject matter expert regarding problem solving techniques and solution implementation
- Lead and direct root cause investigations on internal and external quality concerns and manage the completion of Quality Notifications to include any assigned corrective action activities
- Works with Product Development and Manufacturing Engineering to build quality into company's processes
- Communicates with the customers' quality personnel to coordinate quality requirements and resolutions as necessary
- Identifies and pursues tactical and strategic quality initiatives
- Responsible for driving metrics and process improvements relating to quality
- Provides leadership, direction, prioritization, and motivation to attain high levels of employee engagement regarding quality policies, initiatives and activities
- Attends meetings (Production, Engineering, Project Kickoff, Postmortem, etc.) with preparation to provide input and updates as required
- Keeps accurate documentation and performs statistical analysis on quality defects and trends to be shared with the whole organization regarding quality performance
- Provides employee training, coaching, and development
- Leads and supports CI (Continuous Improvement) and lean manufacturing activities/events related to quality
- Identifies process performance improvement opportunities
- Sets compliance requirements for raw material, internal intermediate products, and supplier compliance
- Maintains and complies with ISO accreditation requirements
- Works with site functional leaders and project leaders to implement improvements to production processes that lead to overall increases in product quality
- Works directly with Supply Chain to measure and gage supplier quality performance
- Resolves employee issues through problem resolution
- Manages departmental performance measures, including visual controls, and provides regular progress reports to manager
- Conducts quality training/refresher training with site employees
- Manages employee time regarding punching in and out, absenteeism, and vacation/sick time
- Performs annual evaluation/performance reviews for team members
- Complies with company's business and human resources policies; work rules; safety requirements; quality standards; standard operating procedures; CLIA, HIPAA, OIG requirements and applicable local, State, and Federal regulations
- Responsible for hiring, supervising, assigning work, counseling, disciplining, coaching, training, evaluating, and terminating nonexempt staff members
- Perform other responsibilities as needed and assigned
What you'll need: - BS in quality, Engineering, Business Operations or equivalent or relevant work experience
- 5+ years relevant experience in Quality, Engineering, and/or Operations
- 5+ years supervision experience in a manufacturing environment
- Experience in leading and maintaining an ISO 9001 certification and requirements
- Experience in a Lean Manufacturing environment
- Ability to think strategically, critically analyze details, and solicit facts through go-and-see direct observation and listening to team members
- Demonstrated organizational, planning, and program/project management skills
- Ability to build trusting relationships and communicate effectively at all organizational levels
- Ability to manage multiple projects and changing priorities while working effectively in a team environment
- Strong statistical analysis skills
- Excellent communications skills and ability to communicate ideas with clear understanding of audience and gain commitments that are critical organizational success
- Fluent with MS Office (Excel and Word) required How to Stand Out:
- ASQ, CMQ, or CQE certification preferred
- Blackbelt, Green Belt, or Lean Manufacturing certification
- Certified ISO Auditor
- Experience with Electromechanical assembly and testing
- Experience with CNC machining
- Ability to read blueprints and electrical schematics
- Experience with ERP systems, EPICOR a plus
- Excellent verbal and written communication skills
- Ability to coach and train individuals
- Ability to motivate and influence a team
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