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.