Quality Engineer II

Quality Engineer II

The Quality Engineer II at 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 location on a four 9-hour days and a 4-hour day schedule to support production. You can work either Monday to Thursday 7:00 am to 4:30pm, and Fridays 7:00am 11:00am Or Monday to Thursday 8:00am to 5:30 and Fridays 8:30 am to 12:00 pm.

What You'll Do as a Quality Engineer II

Participate on cross-functional new product development teams with focus on product/service quality and Quality System compliance.

Develop and implement statistically valid sampling plans, designed 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:

• Bachelors' degree in Engineering
• Minimum 3 years' combined Manufacturing/Quality Engineering and/or Quality Systems experience.
• Minimum 3 years' experience working in an ISO certified environment required.

Preferred:

• Experience with medical device or other regulated industries preferred.
• ASQ- Certified Quality Auditor and/or Quality Engineer, QMSR or familiarity with QMSR/GMP regulations preferred.
• Proficiency with MS Office applications such as Excel, Word, PowerPoint.

Other:

• Excellent problem-solving skills
• Has a continuous improvement mindset embracing new ideas and ways to think about a project.
• Maintains strong relationships cross functionally to solve problems collaboratively.
• Communicates through facts and data.
• Demonstrates the technical aspects of the role.
• Applies new technical tools and concepts under the direction of others.
• Invests in growth through formal training or stretch project.
• Completes assigned tasks on time by following standard work processes.
• Thrives on change and adapts to leader-initiated changes.
• Participates in change initiatives to better understand business and project goals.

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

Pay range for this opportunity is $79,687.50 - $98,437.50. This position is eligible for bonus participation.

Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc.

STERIS offers a comprehensive and competitive benefits portfolio.

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life sciences products and services around the globe.

STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law.