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Quality Compliance Engineer

Job Title: Quality Compliance Engineer
Contract Type: Contract
Location: Cork
REF: 88524
Job Published: over 1 year ago

Job Description

Contact: Jenny Dore
Telephone: 021 2066287

Quality Compliance Engineer

Our client a medical device company are looking to recruit a Quality Compliance Engineer for their site in Co. Cork on a temporary basis

What Will I Be Doing?
  • 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
  • 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 analyses 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.

What Will I Be Doing
  • 5 - 10 years' experience in Medical / Regulated Industry.
  • 5 - 10 years Technical Functional / Manufacturing experience
  • 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 results 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.

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

For further information on this Quality Compliance Engineer role in Cork please contact Jenny Dore on 021 2066287 /

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