Senior Quality Engineer

The Senior Quality Engineer in our Mentor, OH location is responsible for managing processes and leading projects to maintain and improve the quality system in accordance with the requirements of, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP and FDA 21 CFR Part 820/211, EU MDR and other applicable standards. This role leads complaint/CAPA investigations, supplier quality improvement actions, operations production and process control improvements, and product and service quality improvements with the use of statistical techniques and other accepted quality principles. This role plans and 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 Monday through Friday 8am to 5pm.

Potential travel up to 10 % for training, to visit supplier or other STERIS sites both domestically and internationally (Mexico).

• Serves as the Core Team Member on cross-functional new product/service development teams with focus on the execution of quality plans and design/service transfer.
• Develops and implements statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis in support of products and service improvements.
• Leads process and product corrective actions and problem-solving activities.
• Reviews the current quality system and recommend / implement improvements as needed.
• Uses data to perform statistical analysis and recommend process / product changes to improve product and service quality.
• Leads projects focused on quality system, product quality and service quality improvements.
• Develops analyses and reports on the performance of the quality system.
• Leads supplier audits and corrective actions.
• Leads and supports internal and external quality system audits.
• Instructs other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
• Collaborates with other departments and facilities within the company on quality related issues.
• Supervises Quality Engineers and other Quality staff in the execution of their assigned duties and objectives.
• Maintains product integrity and quality through the evaluation and disposition of nonconforming materials and processes.

Required:

• Bachelor's Degree in Engineering.
• Minimum of 5 years of related experience required. (Manufacturing/Quality Engineering and/or Quality Systems).
• Minimum of 5 years of experience working in an ISO certified environment.
• Experience with medical device or other regulated industries.
• Quality Management System Regulation FDA (QMSR) Certification or familiarity with QMSR/GMP regulations.
• Ability to travel up to 10% for training or to go to supplier or other STERIS sites both domestically and internationally (Mexico).

Preferred:

• ASQ Certification, preferred.
• Project Management skills and experience.
• Experience with design transfer, process harmonization and sustainability.
• Knowledge of Track Wise, Windchill PLM, or other similar systems.
• Knowledge of ISO 13485 regulations.

Other:

• Shares technical knowledge with others in the team.
• Identifies technical problems and provides innovative solutions.
• Generates alternatives and takes reasonable risks while solving technical problems.
• Generates detailed, high quality technical documentation to capture and communicate designs.

• Completes tasks on time with minimal supervision while identifying potential risks.
• Drives improvements in processes for better efficiency.
• Utilizes advanced tools and best practices to track product and process metrics.
• Mentors team members on timely task completion and actively participates in brainstorming sessions.

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