Quality Engineer

Marmon Holdings•Sault Ste. Marie, MI

About The Position

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.

Requirements

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

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/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