On behalf of my client, I am recruiting for a Quality Engineer.
The successful candidate will 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.
- 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.
- 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
- Ability to read, analyze, and interpret technical data, and technical procedures.
- Ability to prepare Power point presentations and effectively present information while responding to questions from groups of managers, clients, and customers.
- Excellent attention to detail and ability to work with a sense of urgency and have remain impartial and objective.
- Excellent decision-making ability
If you are interested in applying for this role, please call Ciara on +353 1 2784671 or email firstname.lastname@example.org
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com