Job Title: Senior Quality Engineer
Rush, NY, US, 14543
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.
• Experience working on cross-functional teams and on own initiative.
• Demonstrated excellent organizational, oral and written communications skills.
• Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint. Experience with SAP ERP or other ERP system preferred.
#LI-KL1
Pay range for this opportunity is $78,500.00 - $109,987.50. This position is eligible for [BONUS PARTICIPATION] OR a [INSERT COMMISSION RATE RANGE, IF APPLICABLE] commission.
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.
Employees (and their families) may enroll in our company-sponsored medical, dental, vision, flexible spending, health savings account, voluntary benefits, supplemental life/AD&D plans and the company’s 401k plan. Employees are covered by an employee assistance program (also available to household members) and long-term disability. Full-time Employees are also eligible for short-term disability. Full-time Employees will also receive Paid Time Off (PTO) based on years of service and paid holidays. Part-time Employees working 20 or more hours receive a pro-ration of the full-time PTO allocation and paid holidays based on their standard hourly work week. Full-time Employees are eligible for four weeks of paid parental leave. Part-time Employees also receive paid parental leave, pro-rated based on their standard hourly work week.
HuFriedyGroup is an Equal Opportunity Employer. We are committed to equal employment opportunity and the use of affirmative action programs 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. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.
Rush, NY, US, 14543
Nearest Major Market: Rochester
Job Segment:
Senior Quality Engineer, Quality Engineer, Medical Device Engineer, ERP, Infection Control, Engineering, Technology, Healthcare