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Quality Assurance Specialist - Manufacturing

Job Title: Quality Assurance Specialist - Manufacturing
Contract Type: Contract full-time
Location: Galway
Industry:
Salary: Salary available on application
REF: QASJR
Contact Name: John Reid
Contact Email: johnr@rftgroup.ie
Job Published: about 2 years ago

Job Description

Quality Assurance Specialist – Manufacturing:


Our client a leading Multinational Healthcare company now required an experienced Quality Engineer to lead & project manage quality service projects within a manufacturing environment, for our client based in Galway.

The successful candidate will lead investigations into customer complaints, to minimise recurring complaints and complete all associated documentation in a GMP environment.

All Quality issues are resolved in line with the CAPA system for the site.

Responsibilities for Quality Assurance Specialist – Manufacturing:
 

  • Summarizes, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings.
  • Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product
  • Participates in Customer Complaints investigation for areas under their control.
  • Continually seeks to drive improvements in product and process quality.
  • Knowledgeable on QSR and ISO/MDD standards, constantly promoting awareness of best industry practices, making appropriate decision on a daily basis utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisions.
  • Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints.
  • Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
  • Knowledgeable on Risk Management, BSEN 14971 requirements.
  • Compiles and analyses operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
  • May participate directly in a new product/technology transfer to ensure compliance to all internal and regulatory requirements.
  • Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.
  • Gives technical guidance to Associate Quality Engineer, Technician and Inspection staff.
  • Is a good team member, fully motivated to achieve and demonstrate best practices in line with the department and Site objectives
  • Deals with suppliers, other engineering disciplines within and outside of the Site and customers should the need arise.

 

Requirements of Quality Specialist - Manufacturing:
 

  • Honours Bachelor’s Degree in; Sciences, Engineering or similar.
  • 4+ years’ experience in resolving customer complaints through leading investigations, in line with a Quality Management System.
  • Strong experience in using problem solving tools, preferably six sigma or similar.
  • Proven experience with Risk Management and Continuous Improvements.


 

Please send an up to date CV and cover note to John Reid at the RFT Group johnr@rftgroup.ie / 01-2302400 / www.rftgroup.ie

The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.