Position Summary The Quality Analyst is responsible for assisting in administration of the quality management system at a site to assure adherence to ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO …
Skills: Quality management systems, ISO 9001, ISO 13485, FDA 21 CFR Part 820, CAPA investigations
Position Summary The Specialty Services Technician acts as Trusted Advisor to STERIS Customers in service of cleaning large hospital sterilizer equipment, as part of a high performing team. The Technician provides on-sit…
Position Summary The Quality Manager in our Coon Rapids, MN Applied Sterilization Technologies (AST) facility is responsible for leading quality improvement for an AST processing or lab facility. This position leads impl…
Skills: Quality Management Systems, ISO 13485, ISO 9001, FDA 21 CFR Part 820, Regulatory Compliance
Position Summary The Mechanical Engineering Designer is responsible for creating blueprints, schematics, BOMs, and varied complexity mechanical designs using computer-aided design software and is also responsible for the…
Skills: Mechanical design, Computer-aided design, Blueprint creation, Schematics, System integration
Position Summary The Quality Control Supervisor in our Plymouth, MN location leads a team of Quality Technicians or Inspectors focused on incoming or final product/component inspection. The Quality Control Supervisor dev…
Skills: Quality Control, Team Leadership, Quality Management Systems, Regulatory Compliance, Data Analysis
STERIS is a well-established company operating in the medical equipment industry, specifically in decontamination, sterilization, and infection prevention technologies. Recognized for its expertise, safe work environment…
Skills: Mechanical assembly, Blueprint reading, Hand tools, Surface inspection, Quality control
Position Summary As a Consumable Territory Manager at STERIS, you are the primary contact and sales consultant responsible for selling and supporting the Reprocessing Consumable portfolio of products. You will be respons…
At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. HOW YOU WILL MAKE A DIFFERENCE About Us At STERIS In…
Skills: Flexibility, Teamwork, Integrity, Working Under Pressure, Accountability
Position Summary As a CNC Machinist III-2nd Shift you will be responsible for setup and operate Computer Numerically Controlled (CNC) lathes and/or mills. Primarily responsible for setting up and operating equipment with…
Skills: CNC machining, Lathe operation, Milling center operation, Blueprint reading, Process routers
Bakersfield, California, United States · Remote OK
$69k–$89k/yr
Mid level$285K raised
Summary Are you mechanically inclined with a knack for hands-on work? Do you enjoy a flexible schedule and working independently, but also have the support of a team? The Equipment Service Technician is a remote based Cu…
Skills: Troubleshooting, Mechanical repair, Medical equipment maintenance, Installation support, Time management
Position Summary The Quality Analyst in the STERIS Applied Sterilization Technologies (AST) Chester, NY facility is responsible for assisting in administration of the quality management system at a site to assure adheren…
Skills: Quality Management Systems, ISO 9001, ISO 13485, FDA 21 CFR Part 820, CAPA
Position Summary The Material Handler will ship, receive, store, and track inventory, and ensure that parts are handled in accordance with Company and Federal standards. Shift Hours: 10:00 AM - 6:30 PM Monday - Friday Wh…
Position Summary The Quality Specialist in our Plymouth, MN location is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 82…
The Role As a Life Sciences Inside Sales Representative (ISR) at STERIS, you are responsible for indirectly impacting sales growth by providing comprehensive and technical sales support to current and potential Customers…
Position Summary About you: Do you want to spend your working time making a difference in the world around you? Are you motivated by impactful work? Do you have a passion for excellent quality standards, driving business…
Position Summary The Buyer I is responsible to identify and select suppliers, negotiate prices and terms with and establish and manage relationships with designated suppliers, will manage the purchasing cycle and will ad…
Skills: Supplier management, Negotiation, Purchasing, Inventory control, ERP systems
Position Summary The Manufacturing Training Specialist in our Plymouth, MN location is responsible for creating training content, leading On-the-Job (OJT) and classroom training of manufacturing employees, coordination o…
Skills: Training content creation, On-the-job training, Classroom training, LMS management, Process improvement
Position Summary The Supplier Quality Engineer I in our Plymouth, MN location is responsible for maintaining and improving the quality system in accordance with the requirements of, as appropriate, the following standard…
Position Summary The Senior Manager, Quality Systems assumes overall responsibility in ensuring that their site(s)/operations maintain operational and quality systems in a state of compliance to domestic and internationa…
Skills: Quality management systems, Regulatory compliance, ISO 9001, ISO 13485, FDA 21 CFR Part 820
Position Summary STERIS is a well-established company operating in the medical equipment industry, specifically in decontamination, sterilization, and infection prevention technologies. Recognized for its expertise, safe…
Skills: Manual dexterity, Inventory management, Order picking, Communication skills, Safety compliance
The Quality Analyst manages quality system policies, leads CAPA investigations, and ensures site adherence to regulatory standards like ISO and FDA. They also provide technical oversight to quality technicians and coordinate product releases involving non-conformances.
Requirements
Candidates must possess a Bachelor's degree in a scientific or technical field and 1-5 years of experience in manufacturing or quality engineering. Proficiency in ISO-certified environments and knowledge of FDA QSR or EU GMP regulations are required.
Full job description
Position Summary
The Quality Analyst is responsible for assisting in administration of the quality management system at a site to assure adherence to ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137 and/or ISO 11135 and other applicable regulatory standards. This role leads complaint/CAPA investigations, supplier quality improvement initiatives, continuous improvement initiatives and countermeasures 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. The Analyst also supports production and quality operations by coordinating and performing problem-solving investigations, pre-reviews and final acceptance/run release of processing runs that contain non-conformances. Responsible for the activities related to quality and regulatory compliance to ensure all product processing requirements are met in accordance with Customer specifications including calibrations, dosimetry results, generation of test methods, audits, scheduling, validations, record keeping and reporting.
What You'll Do As a Quality Assurance Analyst
Coordinate day-to-day tasks and direction for Quality Technicians/Senior Quality Technicians by providing technical support, mentoring and oversight.
Responsible for oversight of all product and/or report pre-reviews and releases conducted by Quality Technicians/Senior Quality Technicians.
Responsible for executing product and/or report releases for all processing runs/lab samples containing a non-conformance, including management of Customer communication and leading the associated non-conformance investigations.
Initiate and/or participate in corrective actions, problem-solving and continuous improvement activities.
Perform internal audits at other AST facilities, including identification of non-compliances and report generation. Responsible for managing remediation of internal audit observations assigned by site Quality Manager.
Manage creation of new quality system policies and procedures and revisions to existing policies/procedures.
Review collected data to perform statistical analysis and recommend process 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.
Overall responsibilities include commitment to ensure external and internal requirements ar met according to documented policies, procedures, standards and regulations.
Perform other duties as assigned.
The Experience, Skills, and Abilities Needed
Bachelor's Degree in a scientific or related technical field.
1-5 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
1-5 years of experience with medical device or other regulated industries preferred.
1-5 years of experience working in an ISO certified environment required.
Working knowledge of FDA QSR/ EUGMP regulations strongly preferred.
What STERIS Offers
We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being, and financial future.
Here is a brief overview of what we offer:
Market competitive pay
Extensive paid time off and (9) added holidays
Excellent healthcare, dental, and vision benefits
Long/short term disability coverage
401(K) with company match
Maternity and parental leave
Additional add on benefits/discounts for programs such as pet insurance
Tuition reimbursement and continued educational programs
Excellent opportunities for advancement in a stable long-term career
#LI-BN1
Pay range for this opportunity is $85,000 - $93,000. 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. Click here for a complete list of benefits: STERIS Benefits
Open until position is filled.
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. For more information, visit www.steris.com.
If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.
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. 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.
The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.
WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD
Industry
Medical Equipment Manufacturing
Company size
10,001+ employees
Founded
1985
Headquarters
Mentor, OH
LinkedIn followers
164,805
Total funding
$285K
STERIS is a leading provider of infection prevention and other procedural products and services, focused primarily on healthcare, pharmaceutical and medical device Customers.
MISSION
WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life science products and services around the globe.
VISION
We strive to be a GREAT COMPANY. We provide world-class products and services for our Customers, safe and rewarding work for our people, and superior returns for our Shareholders.
• $6 Billion in revenue in FY26
• More than 18,000 Associates worldwide
• Over 4,000 Customer-facing professionals
• Listed on the New York Stock Exchange under the symbol “STE”
To learn more, visit www.steris.com.
Want to join the team? View and apply for open roles at careers.steris.com.
WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD
Industry
Medical Equipment Manufacturing
Company size
10,001+ employees
Founded
1985
Headquarters
Mentor, OH
LinkedIn followers
164,805
Total funding
$285K
STERIS is a leading provider of infection prevention and other procedural products and services, focused primarily on healthcare, pharmaceutical and medical device Customers.
MISSION
WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life science products and services around the globe.
VISION
We strive to be a GREAT COMPANY. We provide world-class products and services for our Customers, safe and rewarding work for our people, and superior returns for our Shareholders.
• $6 Billion in revenue in FY26
• More than 18,000 Associates worldwide
• Over 4,000 Customer-facing professionals
• Listed on the New York Stock Exchange under the symbol “STE”
To learn more, visit www.steris.com.
Want to join the team? View and apply for open roles at careers.steris.com.