STERIS · 16 hours ago
Senior Quality Engineer
STERIS is a company focused on providing innovative healthcare and life science product and service solutions globally. The Senior Quality Engineer is responsible for managing processes and leading projects to maintain and improve the quality system while ensuring compliance with various standards and leading quality improvement initiatives.
Responsibilities
Serve 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
Develop and implement statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis in support of products and service improvements
Lead process and product corrective actions and problem-solving activities
Review the current quality system and recommend / implement improvements as needed
Use data to perform statistical analysis and recommend process / product changes to improve product and service quality
Lead projects focused on quality system, product quality and service quality improvements
Develop analyses and reports on the performance of the quality system
Lead supplier audits and corrective actions
Lead and support internal and external quality system audits
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
Supervise Quality Engineers and other Quality staff in the execution of their assigned duties and objectives
Maintain product integrity and quality through the evaluation and disposition of nonconforming materials and processes
Perform all other duties as assigned
Qualification
Required
BS Chemical Engineering, Biochemical Engineering, or Biomolecular Engineering
Minimum of 6 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience
Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint
Minimum of 6 years of experience working in an ISO certified environment required
Preferred
Minimum of 1 year of experience working in a manufacturing environment
Minimum of 6 years of experience with medical device, pharmaceutical or other regulated industries preferred
Experience with statistical analysis software and Visio preferred
ASQ, QSR or familiarity with QSR/GMP regulations preferred
Ability to manage external Customer and FDA audit process
Ability to manage the complaint handling processes to ensure Customer responsiveness and product and process improvements
Benefits
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
Company
STERIS
STERIS is a leading provider of infection prevention and other procedural products and services, focused primarily on healthcare, pharmaceutical and medical device Customers.
H1B Sponsorship
STERIS has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (26)
2024 (28)
2023 (15)
2022 (33)
2021 (18)
2020 (19)
Funding
Current Stage
Public CompanyTotal Funding
$0.28M2010-05-21Post Ipo Debt· $0.28M
1998-12-01IPO
Leadership Team
Recent News
2025-11-05
Company data provided by crunchbase