Quality Systems Specialist
About The Position
The Quality Specialist at STERIS’s Mentor, Ohio site assists with administration of site quality functions to help ensure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Parts 820 and 211, EU MDR, and other applicable regulatory standards. The role coordinates document control transactions, site record retention, calibration, and inspection activities. It also facilitates customer complaint investigations, assists with audit coordination, supports supplier quality and customer assessments, and supports risk management activities where appropriate. The specialist may track and trend quality data and support the site Management Review process. This position works onsite in Mentor, Ohio, Monday through Friday.
Requirements
- Associate degree and a minimum of 2 years of experience in Quality in a regulated industry, such as FDA- or ISO 13485-regulated work; alternatively, a high school diploma or GED and 6 years of experience in a regulated industry.
- Strong interpersonal communication and collaboration skills.
- Knowledge of Microsoft Office Suite applications, including Excel and PowerPoint.
- Demonstrates a customer-first mindset and responds with a sense of urgency.
- Collaborates professionally with others to support team actions.
- Effectively manages work tasks, is detail oriented, and strives for continuous improvement.
- Ability to analyze technical issues and cope with change and shifting priorities.
- Constructs clear written communication and keeps the manager and coworkers informed.
Nice To Haves
- Experience working in a manufacturing environment.
- Previous Quality Specialist experience and a strong understanding of Quality Management Systems.
- Experience working with applications such as TrackWise or Windchill.
Responsibilities
- Complete document control transactions.
- Manage customer complaint investigations and complete complaint documentation.
- Facilitate CAPA and NCR investigations and may coordinate investigation documentation.
- Review DHRs and support batch record release.
- Manage site record retention practices.
- 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.
Benefits
- Market-competitive pay and eligibility for bonus participation.
- Extensive paid time off and additional holidays.
- Healthcare, dental, and vision benefits.
- Long- and short-term disability coverage.
- 401(k) with company match.
- Maternity and paternity leave.
- Additional benefits and discounts, including programs such as pet insurance.
- Tuition reimbursement and continuing education programs.
- Opportunities for advancement in a stable, long-term career.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
