Quality Specialist

About the role

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.

Responsibilities

• 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.
• Care for site inspection activities and recordkeeping.
• Care for coordination of 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.

Requirements

• 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, 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.

Preferred

• 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

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
Tuition Reimbursement and continuing education programs
Excellent opportunities for advancement in a stable long-term career
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.

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.