Quality Engineer

Marmon Holdings, Inc.•Sault Ste. Marie, MI

53d•Onsite

About The Position

Precision Edge Surgical Products Company LLC, a part of the global industrial organization Marmon Holdings (backed by Berkshire Hathaway), is seeking a Quality Engineer. This role involves making a positive impact, leading at every level, and fostering a culture of empowerment. The Quality Engineer must have excellent attention to detail and a full understanding of manufacturing processes. Previous experience with multiple pieces of measuring equipment is required, as is experience working with internal and external customers. Following proper documentation processes is essential.

Requirements

BS in Engineering required
Must have very good attention to detail
Full understanding of the manufacturing processes
Previous experience with using multiple pieces of measuring equipment
Experience working with internal and external customers is a must
Following proper documentation processes is essential
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

Nice To Haves

6 sigma, SPC preferred
3 + years experience in quality engineering preferred

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