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Quality Specialist

2 weeks ago

Bishop's Stortford, United Kingdom STERIS Full time

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

**Position Summary**:
This position is responsible for assisting in administration of the quality functions at the site in accordance with the requirements for ISO, FDA QSR, and STERIS policies. This would include but is not limited to: review quality records (i.e. Device History Records), inspection, complaint investigation, record management, data trending, and document control functions.

**Duties**:
Document Control transactions in change control management system.
Coordinate the retention of the records
Coordinate calibration activities
Support lean activities.
Faciliate Investigations (complaints, failure, etc.)
Track and Trend Quality System Data
Coordinate Internal and Customer Audits
Coordinate Supplier Quality and Customer Assessments
Batch Record Release / Approve DHRs
Report into Management Review.

**Required Experience**:

- 1 year experience preferred with degree in Quality in a regulated industry (i.e. FDA/ISO 13485) or 3 year experience in Quality in a regulated industry (i.e. FDA/ISO 13485) with no degree.
- Associate’s degree in related technical field (i.e. Engineering, Chemistry, Biology) preferred.
- Ability to work in a fast-paced environment with strict deadlines
- Technical Excellence (Learn) - Analyzes and solves technical problems. Seeks input from more experienced individuals to improve quality of deliverables. Generates detailed, high quality technical documentation (i.e.Complaints, CAPAs).
- Strategic Thinking
- Gains perspective through experiences and developing new skills.
- Execution / Accountability - Provides clear and accurate data regarding product and process measurables.
- Judgement / Decision Making - Contributes positively to team decisions and actions

**Preferred Experience**:
**Skills**:
STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics. We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 associates and Customers in more than 100 countries.

STERIS strives to be an Equal Opportunity Employer.