- Reference: CJ44203
- Job Type: Contract
- Location: Cork, Cork City, Munster
- Category: Production
To provide Quality Engineering and Process Excellence support in a defined Business Unit / Value Stream environment for In-Process, Finished Product, First Articles & New Product Introduction.
- Actively support all Compliance Initiatives with the Value Stream and Plant
- Actively support all defined Value Stream and Plant goals and objectives.
- Work as an integral member of authorised Value Stream Process Excellence initiatives
- Identify projects to resolve scrap, reprocessing and special causes that have a negative impact on Value Stream and Plant Goals and Objectives.
- Compile Quality Process Specifications for new/transferred products/processes
- Validate new/changed production processes/systems with Business Unit personnel
- Design and validate Quality System processes where appropriate (CSV and Inspection Process)
- Reviews product designs, test protocols and co-develop critical characteristics/tolerances for initial testing and validations and subsequent routine manufacturing controls.
- Conduct internal Quality System Audits as necessary
- Participates in design evaluations where appropriate
- Participates in process evaluations (e.g. FMEAs).
- Devises and implements methods and procedure for inspecting, testing and evaluating plans for subsequent routine production.
- Support Quality System activities within manufacturing cells such as Internal Audits, complaint investigations, close call and corrective action investigations.
- Perform/document dimensional/visual inspections and non-conformance and deviations as required
- Manage a variable workload to meet operational requirements.
- Ensure that all Health, Safety and Environmental requirements are fulfilled.
- Process Excellence – Continuous Process Improvement
- Process/Quality Input for validation processes and new product introduction
- Inspection of products & processes
Key Competencies Required:
- High Attention to Detail
- Pro-active approach to Work
- High Standards
- Excellent Communication Skills
- Analytical Skills
- Team Player
- High level of Numeracy
- Highly Computer Literate
- Planner & Organiser
- Active Listener
- Continuous Improvement Focus
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.
- 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.
- 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 a confidential discussion and more information on the role, please contact Emer O’ Callaghan on 021 4911061 or email firstname.lastname@example.org
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
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