Quality Specialist

Quality Specialist

The Quality Specialist in our St. Louis, Missouri manufacturing facility 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. In this role, you will coordinate 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 position requires working onsite in our St. Louis, Missouri manufacturing facility Monday through Friday from 8am to 5pm.

What You'll 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 (Device History Record) 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 Engineering or Scientific field, and a minimum of 2 years of experience in a Quality function within a regulated industry (i.e. FDA/ISO 13485).

• In lieu of a degree, a high school diploma/ GED and a minimum of 6 years of experience in a regulated industry (i.e. FDA/ISO 13485).

Preferred:

• Experience working large data sets and analyzing trends.
• Proficiency using Excel to export data and manipulate data sets using pivot tables or other methods.
• Understanding of national sampling standards (ANSI -Z1.4).

Other:

• Demonstrates a "Customer first" mindset. Responds with a sense of urgency.
• Collaborates with others. Works in a professional manner to support team actions.
• 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.
• Constructs clear written communication. Keeps manager and co-workers informed.
• Working familiarity of common desktop applications including Microsoft Office applications such as Excel and Word.

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 career

Pay range for this opportunity is $58,000 to $70,000. 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.

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.

If you need assistance completing the application process, please call View phone number on click.appcast.io. 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.

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.