Precision Edge Surgical Products Company LLC · 5 hours ago
Quality Engineer
Sault Ste. Marie, MI
Full-time
Onsite
Mid Level
3+ years expPrecision Edge Surgical Products Company LLC is part of the global industrial organization Marmon Holdings, committed to making a positive impact in the world. The Quality Engineer role involves ensuring quality standards in manufacturing processes, interfacing with customers and suppliers, and implementing quality control measures.
HardwareManufacturingMedical DeviceRetail
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
Qualification
Required
BS in Engineering required
3 + years experience in quality engineering preferred
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
following proper documentation processes is essential in this role
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
excellent interpersonal skills, having the ability to interface with all levels of the organization, customers and suppliers
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
Preferred
6 sigma
SPC
Company
Precision Edge Surgical Products Company LLC
Precision Edge is a world-renowned contract manufacturer of fine surgical components, cutting tools and accessories.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase