Position Summary
As an Associate Quality Specialist you will be responsible for administering of all site's quality functions relating to customers and the adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. This role coordinates document control transactions, site record retention, calibration and inspection activities. In addition, the Quality Specialist will facilitate Customer complaint investigations, assist in audit coordination, support supplier quality and customer assessments and support risk management activities where appropriate. This role may also track and trend Quality data and support the site Management Review process.
Shift: 5:00am-3:30pm Monday-Thursday
What you will do as an Assocaite Quality Specialist
Complete document control transactions.
Review customer complaints and complete complaint documentation.
Facilitate CAPA and NCR investigations and may coordinate investigation documentation.
Review DHRs and support batch record release.
Manage record retention practices within the site.
Manage site calibration activities and recordkeeping.
Support site inspection activities and recordkeeping.
Assists in internal and external audits.
Support supplier quality and Customer assessment activities.
Track and trend site Quality data.
Support targeted Lean activities.
Complete other duties as assigned.
The Experience, Skills and Abilities
Required:
High school graduate/GED
Two (2) years experience in a regulated industry (i.e. FDA/ISO 13485)
Other:
Customer Focused: Demonstrates a "Customer first" mindset. Responds with a sense of urgency.
Teamwork: Collaborates with others. Works in a professional manner to support team actions.
Results: Effectively manages work tasks. Is detail oriented and strives for continuous improvement. Ability to analyze technical issues. Ability to cope with change and shifting priorities.
Communication: Constructs clear written communication. Keeps manager and co-workers informed.
Job Knowledge: PC experience and working familiarity of common desktop applications including Excel and Word.
What STERIS Offers
We Value our employees and are committed to providing a comprehensive benefits package that supports your heath, well-being, and financial future.
Here is just a brief overview of what we offer:
* Market Competitive Pay
* Extensive Paid Time Off and (9) added holidays
* Long/short Term disability coverage
* 401(k) with company match
* Maternity & Paternal Leave
* Additional add-ons benefits/discounts for programs such as Pet Insurance
* Tuition Reimbursement and continues educations programs
Pay range for this opportunity is $20.84 - $26.97. 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.
