Principal Quality Process Improvement Expert
|Contact Name:||Larry O’Leary|
Our client, a blue-chip Medtech company based in Galway who has an excellent product development pipeline, now seeks a highly experienced Quality Process Improvements SME who will operate at Management level.
This strategic role will provide focused quality engineering support within new product development, operational and/or system/services support within an FDA regulated environment.
The successful candidate will focus complaint investigations within Quality Assurance and the associated QMS, with the intention of; identifying and scoping out quality projects for process improvements, driving process improvements through technical competence and effective program management and leadership across the site.
This hire will be a Senior Subject Matter expert in the area of process Improvements with proven Quality Management, who has specialized knowledge of process changes and associated various alternatives and their impact on the business.
The ideal candidate will be experienced in operating with a high degree of technical autonomy in developing robust and comprehensive processes for investigation of complaints, complying with all current medical device standards such as 21 CFR Part 820, ISO 13485, MDD and MDR.
Requirements for Principal Quality Process Improvement Expert:
Honours Bachelors Degree in Science, Engineering or similar technical discipline.
Lean or Six Sigma or similar structured problem solving qualifications are preferred.
Project Management qualifications are highly desirable.
10+ years relevant experience in Quality Management or Process Improvement, in GMP environment which is FDA regulated.
Expert in problem solving / process improvements and project management skillsets and application.
Knowledge on product design, manufacture, functionality and/or clinical use environment.
Experience of laboratory controls, equipment sourcing, and validation would be an advantage.
Excellent technical capabilities, communication and organisation skills.
Demonstrated experience delivering results in a matrixed environment.
Ability to travel occasionally internationally for applicable assignment or meetings.
Please phone Larry on +353 1 2302400 / email@example.com
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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