Quality Engineer
Company: STERIS
Location: Mentor
Posted on: January 15, 2021
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Job Description:
STERIS is a leading provider of infection prevention and
procedural products and services, focused primarily on the critical
markets of healthcare, pharmaceutical and research and medical
devices. Our mission is to help our Customers create a healthier
and safer world by providing innovative healthcare and life science
product and service solutions around the globe. We have 12,000
employees worldwide, with over 3,000 in Customer-facing sales and
service roles. Founded as Innovative Medical Technologies in Ohio
in 1985, the company was renamed STERIS in 1987. Many of the
businesses that have been acquired and integrated into STERIS have
much longer operating histories, notably the American Sterilizer
Company founded in 1894. The STERIS Vision is inspired by our
Customers' efforts to create a healthier and safer world, and
guided by our legacy of leadership and innovation; we strive to be
a Great Company. To STERIS, this means we will make a difference by
providing world-class product and service solutions for our
Customers, safe and rewarding work for our People, and superior
returns for our Shareholders.Position SummaryThe Quality Engineer
is responsible for maintaining and improving the quality system in
accordance with the requirements of, as appropriate, the following
standards: IS0 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU
MDR and other applicable standards. This role supports
complaint/CAPA investigations, operations production and process
controls, and product and service quality improvement 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.Duties* Participate on cross-functional new product
development teams with focus on product/ service quality and
Quality System compliance.* Develop and implement statistically
valid sampling plans, designed experiments, capability studies, SPC
and trend analysis.* Initiate and/or participate in process and
product corrective actions and problem-solving activities.*
Update/establish documented work instructions as needed.* Review
collected data to perform statistical analysis and recommend
process/product 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.* Maintain product
integrity and quality through support of evaluation and disposition
of nonconforming materials.* Perform quality system audits and
provide guidance on corrective actions.* Quality oversight of
Third-Party Quality System requirements.* Perform other duties as
assigned.Required Experience* Bachelor's Degree in Engineering
discipline required.* 2+ years of combined Manufacturing/Quality
Engineering and/or Quality Systems experience.* 2+ years of
experience with medical device or other regulated industries
preferred.* 2+ years of experience working in an ISO certified
environment required.* Familiarity with Quality System Regulations
and GMP regulations preferred.* ASQ Certified Quality Auditor
preferred.What STERIS OffersThe 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, holidays, matching 401(k),
annual merit, and incentive plans. Join us and help write our next
chapter.The Quality Engineer is responsible for maintaining and
improving the quality system in accordance with the requirements
of, as appropriate, the following standards: IS0 9001, ISO 13485,
MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable
standards. This role supports complaint/CAPA investigations,
operations production and process controls, and product and service
quality improvement 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.
Keywords: STERIS, Mentor , Quality Engineer, Engineering , Mentor, Ohio
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