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Über
The experience expected from applicants, as well as additional skills and qualifications needed for this job are listed below.
Lead a design quality team to develop and maintain risk management files and provide quality engineering support for new product development and introduction activities. The role requires experience in design quality for Class II and III medical devices.
Key Responsibilities
Perform management responsibilities for direct reports.
Ensure compliance with all applicable regulations and BD procedures.
Manage quality resources assigned to new product development and introduction programs.
Provide QE resources for test method validation, product verification and validation, reliability testing coordination, data evaluation for statistical validity, component qualifications, process capability studies, equipment qualifications, and process validations.
Facilitate risk management process in compliance with appropriate external standards and corporate policies.
Support field assurance investigations and post‑market surveillance activities as required.
Maintain up‑to‑date knowledge of quality assurance, design controls, risk management, statistical techniques, and company products, policies, and procedures.
Ensure compliance to applicable internal and external requirements during the product development cycle and commercialization of new products.
Collaborate with R&D and Engineering to facilitate successful execution of the New Product Development Process and launching of robust products.
Be accountable for QE deliverables within the product development program and ensure projects are properly resourced with well‑trained quality professionals.
Review and approve validation documentation and risk management files.
Participate in regulatory, third‑party, and corporate audits.
Key Requirements
Understand how products are used and impact users so that risk can be managed effectively.
Knowledge of regulatory requirements including 21 CFR 210, 211, ICH Guidelines, ISO 13485, ISO 14971.
Apply quality engineering tools such as sampling plans, root cause analysis, and statistics.
Working knowledge of test method validation, equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies.
Third‑level degree in technical/science or engineering.
Minimum of eight (5) years of experience with Class II or Class III medical devices, including at least 3 years of supervisory experience.
Relevant technical experience in engineering or quality within a federally regulated industry (medical device, pharmaceutical, or life sciences) with experience in design, process, and software validations.
Strong working knowledge of QSR, ISO 13485, MDD/MDR, MDSAP.
Experience conducting quality audits.
Benefits
Competitive and attractive employee compensation package.
Pension contributions.
Health insurance. xcfaprz
Paid holidays.
Location
Wexford | Ireland
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Sprachkenntnisse
- English
Hinweis für Nutzer
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