Quality Line Auditor-Assembly
MPE-Inc
Summary
In this vital role, you will make sure the products we build meet quality standards throughout the assembly process. You will audit assembly lines, inspect and release product, review production records, and work with production and engineering to identify and resolve quality issues.
Job description
Key Responsibilities
- Conduct assembly line audits to verify proper equipment setups, availability of calibrated tools, and adherence to approved work instructions.
- Reinforce Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) with production personnel.
- Review production records (DHRs) for completeness, accuracy, and legibility, and make sure records are archived per Quality System requirements.
- Execute product release, including independent final inspections, sign-offs, and system transactions to authorize shipment of conforming assemblies.
- Evaluate nonconforming material, coordinate 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 make sure personnel are qualified before performing assembly tasks.
- Issue quality alerts to production personnel for complaints and nonconformances to prevent recurrence.
- Document process deviations and in-process changes for approval.
- Share work instruction and process gaps with Process Engineering to support continuous improvement.
- Support evaluation and documentation of rework for assemblies, including product returns.
Qualifications
Education: High school diploma or equivalent required.
Experience and Training:
- 1–2 years of experience in quality in a manufacturing environment, preferably medical device assembly.
- Ability to read blueprints and use measurement tools.
- Experience with nonconformance management and Material Review Board (MRB) processes preferred.
- Intermediate-level Geometric Dimensioning and Tolerancing (GD&T) preferred.
- Familiarity with Good Documentation Practices and production record review.
- Proficiency with Microsoft Outlook and Excel.
- Broad understanding of materials, manufacturing technologies, and processes preferred.
- Experience with ERP and inspection management systems preferred.
Requirements
- High school diploma or equivalent required.
- 1–2 years of experience in quality in a manufacturing environment, preferably medical device assembly.
- Ability to read blueprints and use measurement tools.
- Familiarity with Good Documentation Practices and production record review.
- Proficiency with Microsoft Outlook and Excel.
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Paid Holidays
- Vacation Time
Company overview
MPE-Inc, also known as Midwest Products & Engineering, is a leading medical device manufacturer specializing in custom medical equipment carts and capital equipment commercialization platforms. Founded in 1978 and headquartered in Milwaukee, Wisconsin, the company has established itself as the largest custom medical cart manufacturer in the United States. With over 40 years of industry expertise, MPE-Inc serves blue-chip medical device and technology OEMs through its vertically integrated business model that offers comprehensive "Concept to Completion" solutions. The company's innovative MACH Series provides modular, customizable cart components that accommodate over 95% of medical devices, enabling healthcare OEMs to achieve faster time-to-market, lower costs, and reduced development risks. MPE-Inc's FDA-registered facility maintains ISO 13485 and 9001 certifications, ensuring compliance with rigorous medical device manufacturing standards. The company's unique commercialization platform integrates design, development, manufacturing, and lifecycle support services, addressing critical healthcare needs including ventilator carts during the COVID-19 pandemic. With a workforce of 51-200 employees, MPE-Inc continues to pioneer medical equipment mobility solutions that enhance clinical workflows and patient care delivery across diverse healthcare settings.