On behalf of our client, a medical devices company, we are currently recruiting for a Quality Engineer Team Lead. This is a full-time position based in Bray Co. Wicklow. You will report into the Head of QA/QS.
Purpose of job
To provide guidance on all aspects of reagent manufacturing systems including support in the management of QA activities for Supply Chain of reagent products in Bray to ensure that product and processes meet the required specifications and duties are performed within the regulations.
Role & Responsibilities
· Support the Quality Engineer’s with Quality Event and Audit action activity and reagent/instrument information discussion.
· Support QA Document activities and Product Release activities.
· Support and engage in the internal and external audit programmes, as appropriate.
· Support the Supply Chain activity 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.
· Actively support, monitor, and drive participation in the Investigation Management System across the product lifecycle, including investigation and management of customer complaints.
· Responsible for Quality Event and Internal Audit action investigation, corrective action and disposition approval including verifying that subsequent activities do not adversely affect the ability to meet applicable regulatory requirements.
· Responsible for rework activity review and approval, as appropriate.
· Assist in the review of product and process changes to maintain and meet regulatory guidelines.
· Support review of reagent and instrument risk management files as required.
· Work constructively with team members from Cross Functional teams, Supply Chain, R&D, Marketing, and Technical Support group to attain outcomes. Support and engage with Team members from as appropriate.
· 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
· At least 2-5 years + industrial experience of which three years in the diagnostic/medical device/pharmaceutical industry
- Demonstrated competence in biochemical techniques and statistical concepts
- Demonstrated knowledge of ISO 13485 and MDSAP requirements
- Quality Auditor
Skills and Behaviours
- Ability to take the initiative and use it to propose and drive solutions
· Ability to read, analyze, and interpret technical data, and technical procedures.
- A working knowledge of modern quality system requirements relating to Supply Chain activities
- Team player – able to give and take direction and to give and receive constructive feedback
- Self-motivation with strong work ethic and organizational skills and ability to prioritize, schedule and plan ahead
· 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.
Language Skills
Fluent English both written and oral.
For a full Job Spec and to apply for this role please call Katie on +353 1 895 5770 or e-mail [email protected]
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 895 5770
