Quality Line Auditor-Assembly

Job Description

Job Description

Quality Line Auditor – $20–$25/hour

At MPE we are dedicated to making a difference in the world through cutting-edge medical technology. Our mission is to be the global leader in design, engineering, and manufacturing solutions for the medical and technology industries. We are committed to creating impactful solutions that improve lives and fostering an environment where our team members can thrive, grow, and contribute to groundbreaking advancements in the medical field.

A better career for you. Creating medical technology for all.

We are seeking a dedicated Quality Line Auditor to join our team.

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.

If you enjoy working in a fast-paced environment where precision and teamwork matter, we’d love to hear from you!

Shift Available: First or Second Shift Available-First Shift 6:00am-2:30pm Monday-Friday; Second shift 2:30pm-11:00pm Monday-Friday

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.

Physical and Mental Demands:

• Continuously sit, read, speak, and use a computer; continuous use of vision, hearing, and comprehension.
• Frequently walk and stand for inspections, use fine motor skills to handle tools and equipment, and apply problem-solving and reasoning to complex information.
• Occasionally make decisions on product quality and disposition.
• Intermittently lift up to 30 pounds.
• Work is performed in a manufacturing environment with moderate noise levels, along with some office and desk work.

Why Join Us?

• Mission-Driven Work: Help deliver medical products that change lives.
• Growth Opportunities: We support career development and internal promotions.
• Comprehensive 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.

If you’re detail-oriented, team-driven, and ready to contribute to life-changing medical technology, apply today and grow your career at MPE.

No relocation or sponsorship available for this role.

MPE, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex (including pregnancy), sexual orientation, gender identity, national origin, ancestry, age, disability, genetic information, marital status, military or veteran status, arrest or conviction record, or any other characteristic protected by federal, state, or local law.

***Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this role. Applicants who need an accommodation during the application or hiring process may contact Human Resources

You should be proficient in:

• GD&T
• ISO 13485
• FDA Regulations
• Standard Operating Procedures (SOPs)
• Hi-Pot (High Potential) / High Voltage Testing
• Good Manufacturing Practices (GMP)
• First Article Inspection (FAI)
• PPAP Process Experience
• Blueprint Reading

Machines & technologies you'll use:

• Calipers and Micrometers