QC Laboratory Specialist
Mentor, OH, US, 44060
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 QC Laboratory Specialist 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 820/211, EU MDR and other applicable regulatory standards.
This position is responsible for performing quality inspection in accordance with the requirements for ISO, FDA QSR, and STERIS policies. This would include but is not limited to testing raw material, in-process, and finished goods using the various analytical instrumentation (i.e. HPLC, GC) and with supervision perform failure investigation.
What We Offer You
The 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
- Paid holidays
- Matching 401(k)
- Annual merit increases
- Annual bonus
Join us and help write our next chapter.
What You Will Do
• Decontaminates, cleans, and sterilizes glassware and other containers.
• Monitors and maintains laboratory equipment including calibration.
• Prepares media and reagents.
• Performs routine product and raw material testing of samples.
• Performs product and raw material testing of samples.
• Prepares reagents, standard solutions, equipment for use, etc.
• Recognizes and communicates unexpected results in a timely manner and completes Out of Specification forms (OOS), Non-conformance Reports (NCR) and Incoming Rejection Forms (IRs) for nonconforming or rejected materials.
• Writes and revises standard operating procedures (SOPs) under supervisor’s direction, using Quality software to change, submit and review documents.
• Participates in Investigations (complaints, failure, calibrations, equipment, etc.).
What Will Help You Be Successful
• Minimum 4 years relevant lab testing in a regulated industry (i.e. FDA/ISO13485) required without associates degree. Bachelor’s degree preferred.
• Ability to work in a fast-paced environment with strict deadlines.
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, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 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.
Mentor, OH, US, 44060
Nearest Major Market: Cleveland
Nearest Secondary Market: Akron
Job Segment:
Laboratory, Testing, Infection Control, QC, Instrumentation, Science, Technology, Healthcare, Quality, Engineering