Our client a leading Multinational Healthcare company now required an experienced Quality Specialist - Operations , this is an initial contract role based in Galway with excellent possibility of been made permanent.
The Quality Specialist - Operations demonstrates commitment to the Quality Policy (patient safety and product quality) through their daily execution of sound quality practices and the maintenance of an effective quality system. Understands and complies with all the regulations governing the quality systems.
Responsibilities for Quality Specialist - Operations:
- 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.
- 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.
- Honours Bachelor's Degree in; Sciences, Engineering or similar.
- 3+ 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 firstname.lastname@example.org / 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.