Our client, a global leader in medical devices is recruiting for a Design Assurance Quality Engineer for their site in Galway.
The Design Quality Assurance Engineer is responsible for providing Quality Engineering input to support Product Design and Commercialisation. Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- 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.
- Provides regulatory compliance, risk management, design control and quality systems expertise to the team.
- Interfaces with R&D, Regulatory Affairs, Clinical, Marketing, Process Development and Manufacturing functions in a project team environment.
- Implement, maintain and update procedures that ensure that R&D documentation constantly meets BSC’s Product Development Process and Design Control requirements.
- Owns and drives Nonconforming Event and Correction and Preventive Action investigations.
- Supports continuous improvement activities, NCEPs, CAPA and Lean initiatives.
- Knowledgeable on QSR and ISO/MDD/MDR 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.
- 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, and customers, other engineering disciplines within and outside of the Site and customers should the need arise.
- Support internal and external regulatory audits.
Qualifications and Experience:
- BS in an engineering/biomedical Engineering discipline with 2-5 years of technical experience (or equivalent)
- MS/ME with 2 years of technical experience
- Working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, MDD/AIMDD, CMDR, JPAL medical device regulations; Ability to understand other medical device regulations and standards.
- Experience in nonconforming material and CAPA methodologies/systems preferred.
- Strong communication, presentation, facilitation, and project management skills.
- Experience working in cross-functional teams and driving projects to completion
- Familiar with Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).
- High sense of urgency and commitment to execution
- Applies continuous improvement principles in development of the quality system.
- Driven, energetic, self-assured professional with high personal integrity
- Knowledge of analytical techniques and statistical analysis
- Ability to develop effective, positive interpersonal relationship
- Medical device or Pharmaceutical experience
- ASQ CQE certification
- Six Sigma Certified Green or Black Belt
For further information on this Quality Engineer role in Galway please contact Alan Prendergast on 086 0462367 / firstname.lastname@example.org
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