Marmon Holdings

Quality Engineer

Posted 2 Days Ago

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Sault Ste. Marie, MI, USA

In-Office

Mid level

Industrial • Manufacturing

The Role

Performs quality engineering activities for medical device manufacturing, including inspection planning, SPC, PFMEA and control plan maintenance, validation, corrective actions, audits, supplier quality, process capability analysis, and Gage R&R studies. The role develops inspection methods, supports manufacturing and customers, maintains documentation, facilitates audits, trains employees, and ensures compliance with ISO 13485, ISO 9001, and FDA medical device quality requirements.

Summary Generated by Built In

Precision Edge Surgical Products Company LLC

As 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
• 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 [email protected], and please be sure to include the title and the location of the position for which you are applying.

Skills Required

Bachelor of Science degree in Engineering
3 or more years of quality engineering experience
Ability to lift 50 pounds
Experience using multiple pieces of measuring equipment
Understanding of manufacturing processes
Knowledge of PFMEAs and Control Plans
Working knowledge of validation activities
Knowledge of Six Sigma and Statistical Process Control
Knowledge of Lean Manufacturing
Knowledge of Measurement System Analysis and Gage R&R
Knowledge of ISO 13485 and/or ISO 9001 quality standards
Knowledge of FDA QSR 21 CFR Part 820 medical device standards
Excellent interpersonal, organizational, analytical, planning, and supervisory skills