Posted on: August 5, 2022
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.
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
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.
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
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
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.
Duties - cont'd
9. Instruct other STERIS employees in quality principles, effective
corrective actions, and valid statistical techniques.
10. Collaborate with other departments and facilities within the
company on quality related issues.
11. Lead quality system programs (i.e. calibration, maintenance,
training, CAPA, complaints, non-conformances, supplier quality,
management review, operational qualifications, document control,
change control, risk management, etc).
12. Overall responsibilities include commitment to ensure external
and internal requirements ar met according to documented policies,
procedures, standards and regulations.
Bachelor's Degree in Science or Other Technology
Five (5)+ years of experience in manufacturing or processing
environment or other technical/scientific 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
1-5 years of experience working in an ISO certified environment
Working knowledge of FDA QSR/ EUGMP regulations strongly
Excellent problem-solving skills
Focus on identification of potential issues and continuous
Experience working on cross-functional teams and on own
Demonstrated excellent organizational, oral and written
Must have PC experience, as well as working familiarity of desktop
applications including Excel, Word, and PowerPoint.
Ability to work in a fast-paced, regulated environment with strict
Mathematical skills including practical application of fractions,
percentages, ratios, - proportions and algebra.
STERIS is a leading provider of products and services that meet the
needs of growth areas within Healthcare: procedures, devices,
vaccines and biologics. -We exist to fulfill our MISSION TO HELP
OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B,
publicly traded (NYSE: STE) company with approximately 16,000
associates and Customers in more than 100 countries.
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
STERIS 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.
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
Keywords: Steris, Worcester , Quality Analyst, Professions , Northborough, Massachusetts
Didn't find what you're looking for? Search again!