Quality Line Auditor-Assembly

MPE-Inc • Milwaukee, WI

1d

About The Position

MPE is seeking a Quality Line Auditor to ensure products meet quality standards throughout the assembly process. The role audits assembly lines, inspects and releases products, reviews production records, and collaborates with production and engineering teams to identify and resolve quality issues. Work is available on either first shift, 6:00 a.m.–2:30 p.m., or second shift, 2:30 p.m.–11:00 p.m., Monday through Friday. The work takes place in a manufacturing environment with moderate noise, along with some office and desk work.

The position requires a high school diploma or equivalent and 1–2 years of quality experience in a manufacturing environment; medical device assembly experience is preferred. The role requires the ability to read blueprints and use measurement tools, familiarity with Good Documentation Practices and production record review, and proficiency with Microsoft Outlook and Excel. Preferred experience includes nonconformance management and Material Review Board processes, intermediate GD&T, broad knowledge of materials and manufacturing processes, and ERP and inspection management systems.

This role involves continuous sitting, reading, speaking, computer use, and use of vision, hearing, and comprehension. It also includes frequent walking and standing for inspections and handling tools and equipment using fine motor skills; occasional quality and disposition decisions; and intermittent lifting of up to 30 pounds. MPE offers career development and internal promotion opportunities. Medical, dental, and vision coverage begins the first of the month after hire; benefits also include a 401(k) with company match, nine paid holidays, and vacation time from day one. Relocation and sponsorship are not available.

Requirements

• High school diploma or equivalent.
• 1–2 years of quality experience in a manufacturing environment.
• Ability to read blueprints and use measurement tools.
• Familiarity with Good Documentation Practices and production record review.
• Proficiency with Microsoft Outlook and Excel.

Nice To Haves

• Experience in medical device assembly.
• Experience with nonconformance management and Material Review Board (MRB) processes.
• Intermediate-level Geometric Dimensioning and Tolerancing (GD&T).
• Broad understanding of materials, manufacturing technologies, and processes.
• Experience with ERP and inspection management systems.

Responsibilities

• Conduct assembly line audits to verify equipment setup, availability of calibrated tools, and compliance with approved work instructions.
• Reinforce Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) with production personnel.
• Review Device History Records (DHRs) for completeness, accuracy, and legibility, and ensure records are archived according to Quality System requirements.
• Release products by conducting independent final inspections, completing sign-offs, and performing system transactions authorizing shipment of conforming assemblies.
• Evaluate nonconforming material, coordinate its disposition, and document investigations and dispositions.
• Participate in assembly line validations by collecting objective evidence and documenting results for approval.
• Maintain operator training records and verify personnel are qualified before performing assembly tasks.
• Issue quality alerts to production personnel concerning complaints and nonconformances to prevent recurrence.
• Document process deviations and in-process changes for approval.
• Communicate work instruction and process gaps to Process Engineering to support continuous improvement.
• Support the evaluation and documentation of assembly rework, including product returns.

Benefits

• Medical coverage, including HSA-qualified and traditional plans, starting the first of the month after hire.
• Dental coverage starting the first of the month after hire.
• Vision coverage starting the first of the month after hire.
• 401(k) with company match.
• Nine paid holidays.
• Vacation time from day one.
• Career development and internal promotion opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED