Job Description
Position Summary The Quality Specialist in our Plymouth, MN location 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 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.
This role requires working onsite in our Plymouth, MN location Monday through Friday 8:00am to 5:00 pm What you will do as a Quality Specialist - Complete document control transactions.
- Manage Customer complaint investigations and complete complaint documentation.
- Facilitate CAPA and NCR investigations and may coordinate investigation documentation.
- Review DHR's and support batch record release.
- Manage record retention practices within the site.
- Manage site calibration activities and recordkeeping.
- Support site inspection activities and recordkeeping.
- Coordinate 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 Needed Required: - Associates degree and two years of experience in Quality in a regulated industry (i.e. FDA/ISO 13485).
- In lieu of a degree, a high school diploma or GED and 6 years of experience in a regulated industry .
Preferred: - Experience working in a manufacturing environment, preferred.
- Previous Quality Specialist experience and a strong understanding of Quality Management Systems.
- Experience with document control and working with online document repositories.
- Experience working with applications such as Propel, Windchill, or SAP.
- Knowledge of MS Office Suite applications including Excel and PowerPoint.
- Previous experience with Customer support including responding to Customer complaints or requests information about product documentation.
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.
What STERIS Offers We value our employees and are committed to providing a comprehensive benefits package that supports your health, wellbeing, and financial future.
Here is just a brief overview of what we offer:
- Market Competitive pay
- Extensive Paid Time Off and added Holidays
- Excellent Healthcare, Dental and Vision benefits
- Long- and Short-Term Disability coverage
- 401(k) with a company match
- Maternity and Paternity Leave
- Additional add- on benefits / discounts for programs such as Pet Insurance
- Tuition Reimbursement and continuing education programs
- Excellent opportunities for advancement in a stable long-term caree
Pay range for this opportunity is $63,750.00 - $78,750. 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
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.
Job Tags
Temporary work, For contractors, Local area, Monday to Friday, Shift work