Quality Analyst
Company: Steris
Location: Northborough
Posted on: August 5, 2022
|
|
Job Description:
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. 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.-- - Duties 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.-- -
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. Education Degree Bachelor's Degree in Science or Other
Technology Required Experience 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 industries preferred. 1-5 years of experience working in
an ISO certified environment required. Working knowledge of FDA
QSR/ EUGMP regulations strongly preferred. Preferred Experience
Skills 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. Ability to work
in a fast-paced, regulated environment with strict deadlines.
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 application status. 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
hours.
Keywords: Steris, Worcester , Quality Analyst, Professions , Northborough, Massachusetts
Click
here to apply!
|