MPE Inc. · 4 months ago
Quality Manager
Sturtevant, WI, Sturtevant, WI, US
Full-time
Onsite
Mid, Senior Level
$95K/yr - $120K/yrMPE Inc. is dedicated to making a difference in the world through cutting-edge medical technology. They are seeking a Quality Manager to oversee the quality function at their manufacturing facility, ensuring compliance with product specifications and regulatory requirements while leading a team of quality technicians.
Industrial EngineeringManufacturingMechanical Engineering
No H1B
Responsibilities
Prioritize, schedule, delegate work assignments, and directly supervise the quality technicians to ensure conformance to customer product specifications, standards and regulatory requirements
Communicate with customers regarding issues, requests and new product introductions
Host customer and regulatory audits
Manage the material review board process, part production approval process (PPAP), first article inspection, internal audit schedule, quality team’s work hours, calibration schedule, quality control plans, and receiving inspection
Assist in measuring parts requiring first article, in process, and final inspection using a Romer Arm, Microview, CMM, or other metrology equipment as necessary
Oversee the review and creation of control plans on prototype builds
Assist in establishing and implementing quality procedures, specifications, testing procedures, and standards for raw materials for in-process and finished products
Process customer returns and facilitate closure of non-conformance cases with the customer
Communicate voice of customer plant wide
Develop training curriculum and train employees in quality-related practices and system requirements
Analyze internal and customer return/complaint data to identify corrective and preventive actions
Participate in cross-functional teams to support continuous improvement projects to improve levels of quality and productivity
Coach problem solving techniques. (5 why, fishbone, pareto, 8D method)
Use capability study and gage reproducibility and repeatability (Gage R&R) six sigma methods to analyze process and measurement variation
Manages complaints, CAPA, non-conforming products per applicable ISO13485 and FDA requirements
Manage inputs and KPI metrics for management review process per ISO13485 and FDA requirements
Maintain Medical Device Files and records per ISO 13485 requirements
Qualification
Required
Bachelor's degree in engineering or quality-related degree or an equivalent experience
Manufacturing experience required; in a leadership role is preferred
Experience in a customer interface role
Experience with customer and FDA audits
Experience in problem identification, resolution and prevention
Experience low-volume, high product mix fabrication processes (Punch Press, Laser cutting, Progressive Die stamping, forming, hardware insertion, welding and metal finishing)
Preferred
Experience in a leadership role
Six Sigma, ISO, and FDA experience preferred
Benefits
Medical (HSA-qualified and traditional plans), dental, and vision—coverage starts the first of the month after hire.
401(k) with company match.
Nine paid holidays and vacation time from day one.
Company
MPE Inc.
MPE Inc.
Founded in 1978
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2019-10-01Acquired
Leadership Team
Hank Kohl
President / CEO
Company data provided by crunchbase