Quality Compliance Specialist – ISO & FDA

We are currently recruiting for a Quality Specialist. This is an excellent opportunity to join the business at a skilled professional level.

The Quality Specialist will be responsible for assisting in administration of the quality functions on site to assure adherence to ISO 13485, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. This role coordinates document control transactions and site record retention. In addition, the Quality Specialist will assist in audit coordination and support validation and risk management activities where appropriate.

• Process document control transactions.
• Review DHRs and support batch record release.
• Support record retention practices within the site.
• Coordinate site calibration activities and recordkeeping.
• Coordinate site inspection activities and recordkeeping.
• Support internal and external auditing processes.
• Support targeted Lean activities.
• Complete other duties as assigned.

• Administration – 3 years experience
• Document control
• QMS experience

• Teamwork:
  Collaborates with others and works in a professional manner to support team actions.
• Results:
  Effectively manages work tasks, details-oriented, strives for continuous improvement, analyzes technical issues, and copes with change and shifting priorities.
• Communication:
  Constructs clear written communication and keeps manager and co-workers informed.
• Job Knowledge: PC experience and working familiarity with common desktop applications including Excel and Word.

STERIS plc provides employment and advancement opportunities without regard to age, disability, gender reassignment, marriage or civil partnership, pregnancy and maternity, race, religion/belief, sex (gender), sexual orientation or any other legally protected characteristic as defined by UK employment law. The Company bases all employment decisions on merit, qualifications, skills, and abilities with the intention that the best candidate is selected for each position.