Quality Engineer II
About The Position
The Quality Engineer II in our Mentor, Ohio Corporate 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. The Quality Engineer II provides quality systems support and project management in an office setting and requires living within a reasonable commute to our Mentor, OH location. Hybrid schedule: Monday through Friday 8am to 5pm. Work onsite Monday, Tuesday and Thursday, and work from home Wednesday and Friday.
Requirements
- Bachelor’s Degree in Engineering.
- Minimum of 3 years in Manufacturing/Quality Engineering and/or Quality Systems experience.
- Minimum of 3 years of experience working in an ISO certified environment.
- Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint.
Nice To Haves
- Experience with medical device or other regulated industries.
- Certifications with ASQ, QSR or familiarity with QSR/GMP regulations preferred.
- Experience with statistical analysis software and Visio preferred.
- Experience with computer software validation and process validation.
- Experience New Product Development (NPD) in a regulated environment.
- Project Management experience, preferred.
Responsibilities
- Participate in cross-functional, new product development teams with a 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.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
