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Senior Quality Specialist

3 weeks ago

Sault Ste Marie, United States Marmon Holdings, Inc. Full time
Welcome to Our Team
Precision Edge Surgical Products is a world-renowned contract manufacturer of fine surgical components, cutting tools, and accessories. As a part of Marmon Holdings, Inc., we pride ourselves on our technical versatility and ability to assist our customers. We understand the fundamental requirement of superior performance from a surgical instrument, and our team takes extreme pride in building quality products that provide a competitive edge for our customers.

About the Job
This position plays a critical role in ensuring that our products meet the highest standards of quality and performance. The successful candidate will be responsible for developing and implementing validation plans, creating project tasks and schedules, and supporting supplier audits to ensure compliance with FDA, ISO, and company standards.

Duties and Responsibilities
- Develop and execute validation plans to support FDA, ISO, and company standards
- Create and manage project tasks and schedules to support overall production scheduling
- Support supplier audits to insure capabilities and evaluate process change requests to align with both the company and customer requests
- Perform hazard and risk analysis for new legacy products
- Link the efforts and communications of both the quality and operations personnel to insure that inspection processes have been verified and documented
- Identify new inspection equipment
- Lead the root cause analysis for any internal product quality issues or customer complaints
- Mentor and train team members

Requirements
- BS in Engineering required
- ASQ Certified Quality Engineer certification (preferred)
- Supervisor or leadership experience (preferred)

Benefits
We offer a comprehensive benefits package including health, dental, and vision insurance, company-paid short and long term disability coverage, company-paid life and AD&D insurance, and voluntary life insurance.