Quality Engineer-Contract | Collins McNicholas

Quality Engineer-Contract

  • Reference: CJ44203
  • Job Type: Contract
  • Location: Cork, Cork City, Munster
  • Category: Production

Job Description

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.

Responsibilities

  • 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
  • GMP

 Key Competencies Required:

  • High Attention to Detail                            
  • Pro-active approach to Work                    
  • High Standards
  • Flexible
  • 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 emer.ocallaghan@collinsmcnicholas.ie

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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  • Emer O'Callaghan
  • Recruitment Consultant
  • 0214911061
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