Quality Compliance Engineer-Contract | Collins McNicholas

Quality Compliance Engineer-Contract

  • Reference: CJ44380
  • Job Type: Contract
  • Location: Cork, Munster
  • Category: Engineering, Technical & Manufacturing

Objectives of Position:

  • The primary objective of the role will be to Identify, define & implement key processes and system improvements such that they are closed loop.
  • Improve site compliance and adherence to GMP/GxP

 

Responsibilities:

  • Process mapping, procedural review and development, work instructions review and deployment site wide.
  • Support QMS integration activity across the site
  • Approvals as defined on Oracle
  • Support the Quality System to ensure on-going compliance and continuous improvement. This role will liaise with various departments to ensure the quality system is in compliance
  • Participate in local change and CAPA boards
  • Ensure timeliness of ECR’s/SCN’s/CAR’s/PAR’s/SCAR’s, Customer SCAR’s,
  • Developing and implementing systems for sustainable compliance and to ensure the system can then be maintained.
  • Focus on key processes, complete a gap analysis, define the appropriate fixes, gain agreement & implement these improvements
  • Conducting Audits to ensure conformance and effectiveness of the Quality System.
  • Data and trend analysis and reporting.
  • Ensures activities and items are in compliance with both company quality assurance standards and applicable regulations.
  • Ensures that established manufacturing inspection, sampling and statistical process control procedures are followed.
  • Ensure compliance to in-house and/or external specifications and standards, such as GMPs and ISO regulations.
  • Evaluates and analyzes the efforts in organizing, documenting, and interpreting inspection support documents and records.
  • Observes and monitors the trends relating to systems and processes and initiates improvements.

 

Requirements

Essential:

  • 5 – 10 years’ experience in Medical / Regulated Industry.              
  • 5 – 10 years Technical Functional / Manufacturing experience (i.e. Eng., QA, Validation, Standards and Systems)
  • Engineer, Technical or Quality Degree Qualified.
  • Action Oriented – ability and proven implementation skills
  • Sound understanding and utilization of Problem Solving Techniques
  • Proficient in the use of Microsoft Word, Power-point and Excel.
  • Good Communications and influencing skills.  This position will require a result focused resilient personality who will identify opportunities for improvements and change, who will realize those improvements in a fast-paced growth focused Medical Device regulated environment, leveraging on his/her strong interpersonal skills.

Desirable:      

  • Experience in working within a Class 3 Medical Device Manufacturing Environment.
  • Six Sigma Green or Black Belt Certified.
  • Experience of report writing and requirements.
  • Experience in New Product Introduction Processes.
  • Experience in Agile

Measurements:

  • Measurements will be tracked against plant metrics
  • Improvement is site compliance QPI.
  • Observed reduction in CAR generation.

 

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
  • Connect with Emer
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