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Job Title:  Quality Specialist

Req ID:  27434
Job Category:  Quality

Bishop's Stortford, HRT, GB, CM23 5GZ

Description: 

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

Full-time, Competitive salary and benefits.

Based at our new Bishop's Stortford facility, 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

  1. Document Control transactions in change control management system.
  2. Coordinate the retention of the records
  3. Coordinate calibration activities
  4. Support lean activities.
  5. Faciliate Investigations (complaints, failure, etc.)
  6. Track and Trend Quality System Data
  7. Coordinate Internal and Customer Audits
  8. Coordinate Supplier Quality and Customer Assessments
  9. Batch Record Release / Approve DHRs
  10. Report into Management Review.

Support risk assessment as needed

Duties - cont'd

Education Degree

  • Bachelor's Degree

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.

1 year experience preferred in a regulated industry (i.e. FDA/ISO 13485)

2. Associate’s degree in related technical field (i.e. Engineering, Chemistry, Biology) preferred. 

Preferred Experience

Skills

1. Ability to work in a fast-paced environment with strict deadlines

2. 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).

3. Strategic Thinking-  Gains perspective through experiences and developing new skills.

4. Execution / Accountability -  Provides clear and accurate data regarding product and process measurables.

5. Judgement / Decision Making -  Contributes positively to team decisions and actions

 

#LI-NB1

 

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.  

Req ID:  27434
Job Category:  Quality

Bishop's Stortford, HRT, GB, CM23 5GZ


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