Senior Quality Engineer

Please Note: HuFriedyGroup was divested from STERIS on May 31, 2024.  We are currently in a transition period, working to re-establish our own HuFriedyGroup Careers site and job posting pages. Until the new site and pages are ready, career opportunities that are specific to jobs at HuFriedyGroup will continue to be published on the STERIS site. Our Talent Acquisition team will be working diligently to ensure a positive and seamless experience for our candidates.

HuFriedyGroup is a leading manufacturer of dental instruments and infection prevention products. Our 10,000-plus products, hand-crafted by highly skilled artisans, are known for their precision, performance, longevity, reliability, and quality. To help dental professionals be The Best in Practice, HuFriedyGroup provides a unique combination of world class products, value-added services, clinical education, and dental community platforms that result in superior clinician performance  and enhanced safety for dental professionals and their patients. Working at HuFriedyGroup is so much more than a job, as every employee has a part in driving and supporting the organization’s inspirational vision to be a global force in advancing dental performance through Best-In-Practice dentistry that improves lives around the world.

Position Summary

At STERIS, the Senior Quality Engineers are 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.

What We Offer You

The opportunity to join a company that will invest in you for the long-term. STERIS couldn’t be where it is today without our incredible people. That’s why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal. We do this by providing:

 

• Competitive salaries
• Healthcare benefits 
• Tuition assistance
• Paid-time off
• Paid holidays
• Matching 401(k)
• Annual merit increases
• Annual bonus

 

Join us and help write your next chapter.

What You Will Do

•    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.
 

What You Will Do - cont'd

•    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. 
•    Perform all other duties as assigned.
 

Education Degree

• Bachelor's Degree in Engineering General

What Will Help You Be Successful

•    Minimum six (6) to ten (10) years of combined Manufacturing/Quality Engineering and/or Quality Systems experience. 
•    Six to ten years of experience with medical device or other regulated industries preferred. 
•    Six to ten years of experience working in an ISO certified environment required. 
•    ASQ, QSR or familiarity with QSR/GMP regulations preferred. 
•    Excellent problem-solving skills  
•    Focus on identification of potential issues and continuous improvement. 
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