STERIS is a leading provider of infection prevention and procedural products and services, focused primarily on the critical markets of healthcare, pharmaceutical and research and medical devices. Our mission is to help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. We have 12,000 employees worldwide, with over 3,000 in Customer-facing sales and service roles. Founded as Innovative Medical Technologies in Ohio in 1985, the company was renamed STERIS in 1987. Many of the businesses that have been acquired and integrated into STERIS have much longer operating histories, notably the American Sterilizer Company founded in 1894. The STERIS Vision is inspired by our Customers' efforts to create a healthier and safer world, and guided by our legacy of leadership and innovation; we strive to be a Great Company. To STERIS, this means we will make a difference by providing world-class product and service solutions for our Customers, safe and rewarding work for our People, and superior returns for our Shareholders.
Position Summary
The Quality 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 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.
Duties
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.
Required Experience
- Associate's Degree
- Two (2) years experience in a regulated industry (i.e. FDA/ISO 13485)
Preferred Experience
Skills
- 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.
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, holidays, matching 401(k), annual merit, and incentive plans. Join us and help write our next chapter.
Competitive pay
Annual merit bonus and incentive plans
Medical, vision, prescription, dental and life insurance
401(k) with a company match
Paid vacation time and paid holidays
On site parking and electrical vehicle charging stations
Tuition assistance
Opportunities for advancement
Job Type: Full-time
Pay: $65,000.00 - $75,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Professional development assistance
- Retirement plan
- Tuition reimbursement
- Vision insurance
Schedule:
- Day shift
- Monday to Friday
Supplemental pay types:
- Bonus pay
Education:
- Associate (Required)
Experience:
- regulated industry: 2 years (Required)
- CAPA/non conformance: 2 years (Required)
- document control: 2 years (Required)
- Quality: 2 years (Required)
Work Location: In person
