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Quality Engineer

  • Job reference: 925191
  • Location: Limerick
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 30/04/2019

Orion Group are recruiting a Quality Engineer on behalf of our Multinational Medical Device Client on an initial 12 month contract based in Limerick.

− Responsible for supporting the activities of Operations / Engineering / Information Management in building product Quality into our products and assuring compliance to the pertinent regulations while at the same time attaining operational effectiveness
− Work with the various departments/groups in development and execution of validation activities associated with new equipment/product or I.M. system upgrades
− Runs /Manages complaint investigation and resolution of same
− Designs and develops validation documentation to support business continuity, new process introductions
− Implementation and co-ordination of the change control process, promotes timely approval of all supporting documentation
− All employees are responsible for minimising both the Environmental and Health & Safety effects of the work that they perform.

3. Education and Experience Required for Role
− Bachelors degree from accredited college
− 3/5 yrs in a Quality function within the Medical Device/ Pharmaceutical industry.
− Have good knowledge of statistical techniques in the use of problem solving/ data analysis.
− Have a proven track record in development/execution of Validation programs in areas of Equipment, Process and Information management
− Ability to demonstrate standards of leadership - Managing Complexity/Credo Values/Innovations/Customer focus.
− Flexible
− Team Player
− Good Influencing Skills
− Project Management Skills
− Good generalist
− Good communication skills
− Methodical

− Be very familiar with the relevant regulatory standards (F.D.A. - Quality System regulations, IS 13485) applicable to the manufacture of Class 111 medical devices to Global markets.

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.
* Positive attitude
* 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

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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