Quality Engineer

Precision Edge; Sault Ste. Marie, Northern (MI, KY); Hybrid; USD 65,000 - 90,000; Full time

Job summary

Precision Edge, part of Marmon Holdings, is seeking a Quality Engineer in Sault Ste. Marie, MI. The role requires a BS in Engineering and 3+ years in quality engineering. You will create inspection plans, support manufacturing processes, and drive CAPA, PFMEA and Control Plans, with strong emphasis on MSA, DOE and SPC.

You will interface with customers and suppliers, applying ISO 13485/ISO-9001 standards and FDA QSR requirements to ensure product quality and process capability.

Qualifications

• BS in Engineering required.
• 3+ years experience in quality engineering preferred.
• Knowledge of ISO 13485 and/or ISO-9001 Quality Systems.

Responsibilities

• Create inspection plans for new and existing product.
• Provide Quality support through manufacturing process.
• Facilitate Corrective and Preventive Actions (CAPA).
• Develop and maintain PFMEA and Control Plans.
• Conduct Gage R&R studies and improve inspection methods.

Skills

Six Sigma

SPC

Lean Manufacturing

Measurement System Analysis

Design of Experiments

Process Capability Analysis

ISO 13485

FDA QSR 21CFR 820

Education

BS in Engineering

Tools

PFMEA

Control Plans

Gage R&R

DOE

Job description

## Quality EngineerApply: Sault Ste. Marie, MI: Full time: Posted Today: JR0000040837Precision Edge Surgical Products Company LLCAs a part of the global industrial organization Marmon Holdings—which 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 • NoneFollowing 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.