Quality Engineer

Precision Edge Surgical Products Company LLC; Sault Ste. Marie (MI); On-site; USD 75,000 - 95,000; Full time

Job summary

Precision Edge Surgical Products Company LLC is seeking a Quality Engineer to ensure product quality and process capability in our Michigan facility. The role requires hands-on experience with measurement equipment, PFMEA, Control Plans, and supporting validations across manufacturing lines.

The ideal candidate has a BS in Engineering and 3+ years in quality engineering, with knowledge of Lean, SPC, Gage R&R, and ISO 13485/QSR 21 CFR Part 820.

Qualifications

• BS in Engineering required.
• 3+ years experience in quality engineering preferred.
• 6 Sigma, SPC preferred.
• Understand PFMEA’s and Control Plans.
• Working knowledge of Validation activities.
• Design and Analysis of Experiments.
• Knowledge of Lean Manufacturing.
• Knowledge of Measurement System Analysis (Gage R&R).
• Process and Performance Capability Analysis.
• Must possess excellent interpersonal skills, having the ability to interface with all levels of the organization, customers and suppliers.
• Knowledge of ISO 13485 and/or ISO-9001 International Quality System Standards.
• Knowledge of the FDA’s QSR 21CFR part 820 Medical Device Standard.

Responsibilities

• Participate in Material Review Board (MRB).
• Participate in New Product Release Review (NPR).
• Create inspection plans for new and existing product.
• Provide Quality support through manufacturing process.
• Facilitate Corrective and Preventative Actions.
• Facilitate Validation activities.
• Create and maintain PFMEA’s and Control Plans.
• Understand and Implement Customer Specific Requirements.
• Facilitate Customer Audits.
• Program inspection equipment.
• Write/Update Work Instructions.
• Use statistical tools to analyze data, make recommendations and improve process capability.
• Develop, implement and maintain a Statistical Process Control program.
• Perform special projects and assignments as defined by the Quality Manager.
• Evaluate and improve inspection systems/procedures. Design and implement new inspection methods and improve current inspection methodology.
• Work with customers and suppliers to standardize inspection methods.
• Perform process capability analysis and recommend improvements.
• Perform Gage R&R studies and recommend improvements.
• Perform Vendor Audits.
• Supplier Quality.
• Train employees as needed

Skills

6 Sigma

SPC

PFMEA

Control Plans

Validation

DOE

Lean Manufacturing

Measurement System Analysis (Gage R&R)

Process Capability Analysis

Interpersonal Skills

Education

BS in Engineering

Job description

Precision Edge Surgical Products Company LLC

As a part of the global industrial organization Marmon Holdings—and is backed by Berkshire Hathaway—you’ll be doing things that matter, leading at every level, and winning a better way.

We’re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone’s empowered to be their best.

Quality Engineer must have very good attention to detail and full understanding of the manufacturing processes.

Must have previous experience with using multiple pieces of measuring equipment.

Experience working with internal and external customers is a must, and following proper documentation processes is essential in this role.

FLSA Status

Salary Exempt

Reports To

Manufacturing and Quality Engineering Manager, Quality Manager, or Quality Engineer III

Education / Experience

• BS in Engineering required
• 3 + years experience in quality engineering preferred

Essential Functions, Knowledge and Competencies

• 6 sigma, SPC preferred
• Ability to lift 50 pounds
• Understand PFMEA’s and Control Plans
• Working knowledge of Validation activities
• Design and Analysis of Experiments
• Knowledge of Lean Manufacturing
• Knowledge of Measurement System Analysis (Gage R & R)
• Process and Performance Capability Analysis
• Must possess excellent interpersonal skills, having the ability to interface with all levels of the organization, customers and suppliers
• Must possess organizational, analytical, planning and supervisory skills
• Knowledge of ISO 13485 and/or ISO-9001 International Quality System Standards
• Knowledge of the FDA’s QSR 21CFR part 820 Medical Device Standard

Responsibility/Authority

• Participate in Material Review Board (MRB)
• Participate in New Product Release Review (NPR)
• Create inspection plans for new and existing product
• Provide Quality support through manufacturing process
• Facilitate Corrective and Preventative Actions
• Facilitate Validation activities
• Create and maintain PFMEA’s and Control Plans
• Understand and Implement Customer Specific Requirements
• Facilitate Customer Audits
• Program inspection equipment
• Write/Up-date Work Instructions
• Use statistical tools to analyze data, make recommendations and improve process capability.
• Develop, implement and maintain a Statistical Process Control program
• Perform special projects and assignments as defined by the Quality Manager
• Evaluate and improve inspection systems/procedures. Design and implement new inspection methods and improve current inspection methodology
• Work with customers and suppliers to standardize inspection methods
• Perform process capability analysis and recommend improvements
• Perform Gage R&R studies and recommend improvements
• Perform Vendor Audits
• Supplier Quality
• Train employees as needed

Supervisory Responsibilities

• None

Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.

We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class.

If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to [e-mail], and please be sure to include the title and the location of the position for which you are applying.

Company Overview

Welcome to the biggest small business you’ll ever find. Part of Berkshire Hathaway, Marmon is a global industrial organization made of 11 industry groups with 30K employees and $12 billion in annual revenue.

As leaders in their respective industries, our 120+ companies thrive on an independent mindset and entrepreneurial spirit. At the same time, they benefit from being part of our industry groups—where they’re able to tap into the expertise and insights of other Marmon companies.

While we’re all unique, we all share a common commitment to doing things that matter, leading at every level, and winning a better way. When you work at Marmon, you're advancing our everyday world and beyond. Our engineering solutions help millions around the world stay connected, healthy, and safe.

Wherever you're at in your career, our people and resources will help you go further. As you grow your skills, you can also move up and around our 120+ companies. Work at a place you can stand behind. We show up to win every day, uphold the highest ethical standards, and always look to put each other in the best position to win.