Manufacturing Quality Control Lead

2 weeks ago


Mentor, Ohio, United States STERIS Full time
About the Role:

We are seeking a highly motivated and experienced Quality Engineer to join our team at STERIS. As a Quality Engineer, you will be responsible for ensuring the quality of our products and services by developing and implementing quality systems, processes, and procedures.

The ideal candidate will have a strong background in quality management, experience working with QMS, and knowledge of regulatory requirements such as ISO 13485, FDA 21 CFR Part 820/211, and EU MDR.

The salary for this position is estimated to be around $90,000 per year, depending on location and experience. Additionally, we offer a comprehensive benefits package, including market-competitive pay, paid time off, excellent healthcare, dental, and vision benefits, long- and short-term disability coverage, 401(k) with a company match, maternity and paternity leave, tuition reimbursement, and continuing education programs.

Responsibilities:

The successful candidate will be responsible for:
  • Developing and implementing quality systems, processes, and procedures to ensure the quality of our products and services.
  • Maintaining and improving the quality system in accordance with various standards such as ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, and other applicable standards.
  • Collaborating with cross-functional teams to ensure product/service quality and Quality System compliance.
  • Developing and implementing statistically valid sampling plans, designed experiments, capability studies, SPC, and trend analysis.
  • Initiating and/or participating in process and product corrective actions and problem-solving activities.

Requirements:

The successful candidate will possess:

A Bachelor's Degree in Engineering or a related technical field.Minimum of 1 year of combined Manufacturing/Quality Engineering/Quality Systems (QMS) experience or minimum of 6 months on-site STERIS internship or co-op experience.Minimum of 1 year of experience working in an ISO certified environment required.Excellent problem-solving skills, focus on identification of potential issues, and continuous improvement.Experience working on cross-functional teams and on own initiative.Demonstrated excellent organizational, oral, and written communications skills.Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint.

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