Quality Engineer

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