Quality Engineer I

Position Summary

The Quality Engineer I in our Mentor, OH location is responsible for maintaining and improving the quality system in accordance with the requirements of, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, and other applicable standards. This role supports complaint/CAPA investigations, supplier quality improvement, operations production and process controls, and product and service quality improvement with the use of statistical techniques and other accepted quality principles. This role executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems.

This position requires working onsite in our Mentor, OH facility during core business hours.

What You'll do as a Quality Engineer

• Participate in cross-functional new product development teams with focus on product/ service quality and Quality System compliance.
• Develop and implement statistically valid sampling plans, design experiments, capability studies, SPC and trend analysis.
• Initiate and/or participate in process and product corrective actions and problem-solving activities.
• Update/establish documented work instructions as needed.
• Review collected data to perform statistical analysis and recommend process/product changes to improve quality.
• Monitor and report on performance metrics.
• Instruct other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
• Collaborate with other departments and facilities within the company on quality related issues.
• Maintain product integrity and quality through support of evaluation and disposition of nonconforming materials.
• Perform quality system audits and provide guidance on corrective actions.
• Perform other duties as assigned.

The Experience, Skills and Abilities Needed

Required:

• Bachelor’s degree in Engineering.
• Minimum of 1 years of related experience required (combined Manufacturing/Quality Engineering/Quality Systems 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 .

Preferred:

• Experience with medical device or other regulated industries preferred.
• ASQ or QSR Certifications or familiarity with QSR/GMP regulations preferred.
• Experience with MATLAB and MS Office applications such as Excel and PowerPoint. Experience with performing data analysis using statistics.
• Ability to present reports or project updates to a variety of audiences.

What STERIS Offers

We value our employees and are committed to providing a comprehensive benefits package that supports your health, wellbeing, and financial future.

Here is just a brief overview of what we offer:

• Market Competitive pay
• Extensive Paid Time Off and added Holidays
• Excellent Healthcare, Dental and Vision benefits
• Long- and Short-Term Disability coverage
• 401(k) with a company match
• Maternity and Paternity Leave
• Additional add- on benefits / discounts for programs such as Pet Insurance
• Tuition Reimbursement and continuing education programs
• Excellent opportunities for advancement in a stable long-term career

#LI-MO1 #Onsite