Quality Engineer
Precision Edge Surgical Products Company LLC · Sault Ste. Marie, MI · 1 mo ago
Quality AssuranceFull-time
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.
About the role
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
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
- Excellent interpersonal skills, with 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
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/Update 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
- Train employees as needed