Quality Engineer - Contract
|Job Title:||Quality Engineer - Contract|
|Job Published:||2 months ago|
Contact: Caroline Kingston
Telephone: 086 8395533
Quality Engineer - Contract
Our client, a medical device company in Limerick are currently looking to recruit a Quality Engineer for their site on a contract basis.
Provides leadership and support to Water Room and Formulations process, and ensures good Quality Engineering practices are in use. Drives continuous improvement through data driven approaches and monitoring of quality systems.
Provides complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes
Utilizes multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO).
Addresses and corrects product and process complaints.
Ensures comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management
Responsible for supporting the activities of Operations/Engineering/information management in building quality into our products and assuring compliance to the pertinent regulations while at the same time attaining operational effectiveness
Leads and executes upgrades to Quality System
Support QA programs in assuring compliance to the pertinent regulation
Identify and lead cost and technical improvements under the departments’ continuous improvement program.
Provide key inputs and leadership into transformational process developments.
Project Management - provide timely and accurate reporting on project activities.
New Product Introductions & Product Transfers
Lead or actively participate in cross-functional teams to ensure New Product Introduction/Research and Development projects are completed in a timely and efficient manner.
Actively interfacing with cross-functional team members, always practicing good team work in support of day to day operating requirements.
Demonstrate strong leadership and a clear identifiable work ethos within the team.
Develop and maintain a Credo & Behavioural Standards based culture within the group.
Ensure effective closure on Quality System documents (Audit Actions, NCR’s, CAPA’s, Maps, etc).
Ensure all process developments, NPI etc are managed in accordance with the Quality management system.
Implementation of safety/environmental requirements on purchase of all new equipment.
Work with team leader to develop and implement strategic engineering Goals & Objectives.
Support the implementation of all engineering and plant strategic initiatives.
All employees are responsible for minimising both the Environmental and Health & Safety effects of the work that they perform
Maintains and develops risk management lifecycle.
Ensuring continuous improvement and understanding of measurement systems used on-site, driving down variance in test methodology.
Develops site knowledge on manufacturing process knowledge, and monitors inputs and outputs to the processes, and implements and drives corrective actions.
Other Skills, Experience and Education
5 yrs experience in a regulated environment.
SIX SIGMA – Certification
Experience in performing Design of Experiments (DOE) and leading Failure Mode Effects Analysis (FMEA)
Experience of the design and qualification documentation standards to current FDA expectations
Knowledge of statistical packages and Microsoft Office systems required.
Proven ability to review and critique Quality Critical technical documents.
A good understanding and working knowledge of FDA and ISO regulations. Desirable
Knowledge of lean manufacturing
Five years’ experience as Quality Engineer working in a cGMP environment preferably in medical device.
Continuous Improvement orientation
Accepting of change
Flexible - Calmly reacts to the unexpected
Credible – Accountable for decisions
Self-Motivated – requires minimal direct supervision.
Results focused – maximizes business benefit from all activities.
Innovation – thinks laterally but within a compliant framework.
Organized – Able to cope with extensive documentation and planning requirements.
Six Sigma or quality engineer certified.
Structured problem solving and decision making skills working in a team environment.
Ability to participate in or leading cross functional project teams
Must have good written and presentation skills and be able to communicate effectively throughout organization
Demonstrated Experience working with data base applications desired
Ability to set priorities while ensuring compliance is not compromised.
Experience in performing Design of Experiments (DOE) and leading
For further information on this Quality Engineer role in Limerick please contact Caroline Kingston 086 8395533/ email@example.com
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