Senior Quality Engineer (Sustaining)
A respected medical device client are currently looking for a Senior Quality Engineer (Sustaining) in South Dublin. The candidate will be accountable for supporting new product development and ongoing Product Life Cycle technical and engineering support through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.
As Senior Quality Engineer, you will;
• Applies consistent and extensive application of technical principles, theories, concepts and quality sciences, tools, and systems with measurable / confirmed results.
• Writes and leads risk management activities including risk management reports and risk analysis.
• Investigates product and process issues, helping to determine root cause, and establishing effective corrective action.
• Provides training for product development teams, continuous improvement teams, and manufacturing plants on best practices. This is done formally and informally.
• Conducts or leads audits as member of a quality system audit team (e.g. SME, etc.)
• Position specific responsibilities include support of the following, however, are not limited to: Design Control, Change control, Risk Management, Process Validations, Identification of CTQ's, Unit Quality Independent Reviewer During Design Reviews, Handling of deviations and non-conformances, Test method validations, Supplier qualification, Software validations, Post Market Surveillance, Situation Analysis, CAPA – Root cause investigation and implementation of corrective / preventive actions, Proper Use of Statistics (Sampling Plans), Advise on Regulations, Liaise with Manufacturing Plants, Provide functional support to cross-functional teams and Internal and external audits.
The successful candidate will be educated to degree level in life sciences or preferably, engineering. You will have;
• Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, and ISO 13485 / ISO 14971
• Experience in the medical device industry with knowledge in the area of customer relations, complaint trending, FDA regulations, GMP and clinical laboratory functions.
• Certified Quality Engineer and Certified Quality Auditor (preferred).
• Training in design of experiments and statistics. Class II / III medical device experience.
• Excellent skills in analytical thinking and problem solving, written and oral communication skills.
• Proficiency in Microsoft Office suite and statistical programs (i.e. MiniTab, SAS).
• Understanding of continuous improvement methodologies including Lean, Six Sigma, and validation.
• Knowledge of metrology/test methods and MSA (Measurement System Analysis / Gauge R&R) skills with the ability to analyze and improve measurement systems.
We are looking for passionate people who aren’t afraid to take smart risks, innovate and are eager to make things happen. This is an amazing opportunity for you to join a fast-growing company with room to develop your skills and experiences in a complex, matrix and international organization.
If you would like further Information you can contact the recruiter directly:
Claire Kenny | Tel: +353 (0) 1 507 9287