Quality Engineer

Recruiter
Tcoag
Employment Type
Permanent
Salary
Not disclosed
Tcoag logo

Job description – Quality Engineer

Job Title

Quality Engineer within the Tcoag Bray QA group 

Reports to

QA/RA Product Manager

Purpose of job

To provide guidance on all aspects of reagent manufacturing systems to ensure that product and processes meet the required specifications and duties are performed within the regulations and the Quality System is maintained.

Essential responsibilities

Promote the Quality system usage and compliance to avoid product field actions, or major noncompliance in external audits. 

Provide guidance on regulatory and quality requirements to ensure consistent reagent product supply is maintained and all quality aspects are met.

Ensure that non conforming equipment, suppliers, manufacturing activities, reworks and testing activities, are noted and addressed for appropriate actions to ensure that product safety and effectiveness is addressed.

Ensure participation in the Investigation Management System is addressed across the product lifecycle, including investigation of customer complaints where needed. 

Assist in the review of product and process changes to maintain and meet regulatory guidelines.

Maintain and update reagent and instrument risk management files as required by regulatory guidance. 

Work constructively with team members from Cross Functional teams, Supply Chain, R&D, Marketing, and Technical Support group to attain outcomes. 

Communicate progress on a frequent basis and maintain metrics as needed. 

Qualifications

  • An advanced life science degree with experience in medical devices or biological sciences 
  • 2-5 years + industrial experience of which three years in the diagnostic/medical device/pharmaceutical industry) 
  • Demonstrated competence in biochemical techniques and statistical concepts.  
  • Experience in the field of Haemostasis/ IVD industrial experience would be advantageous

Skills and Behaviours 

  • Ability to read, analyze, and interpret technical data, and technical procedures.
  • Ability to prepare Power point presentations.
  • Ability to effectively present information and respond to questions from groups of managers, clients, and customers. 
  • He/She will pay attention to detail and work with a sense of urgency and have the ability to be impartial and objective. 
  • He/She will have excellent decision making ability.
  • He/She will be an active learner.

Language Skills

Fluent English both written and oral.

The above requirements are not exhaustive and are provided to show the most common tasks and may be amended or updated as required.