Senior Quality Engineer - Design Assurance
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As a Design Assurance Quality Engineer (QE), you will play a key role in ensuring that new product development and sustaining projects meet stringent quality and compliance standards. Acting as the Quality representative on project core teams, you will oversee design controls, risk management, and change control processes while driving adherence to global regulatory requirements.
Main Responsibilities
Be the Design Assurance Quality Engineer on project core teams for design change projects and develop close relationships with core team members and extended quality functions as needed for the project.
Contribute to the formation and ongoing management of DHF documentation.
Lead risk management activities within the project.
Drive compliance management activities (e.g., IEC 60601) on the project with support from the Compliance Engineer.
Demonstrate a patient-first approach to quality engineering.
Support the creation and implementation of verification and validation activities.
Work closely with R&D functions to ensure comprehensive testing of product requirements and execution of the V&V plan.
Review and approve testing procedures and documentation.
Review and challenge the statistical rationale and data analysis within the test protocol and reports.
Assess and authorize related execution deviations.
Assist/conduct failure investigations and problem-solving sessions.
Manage software issue tracking per IEC 62304 to ensure issues are logged, risk assessed, and dispositioned appropriately.
Ensure compliance across projects for design control, risk management, and change control processes.
Advocate for a strong quality culture within project core teams.
Support other QMS activities outside of projects, such as CAPA, field assessment, and operations engineering assessments.
Qualifications
Relevant degree or equivalent experience (engineering degree preferred) or a minimum of 5 years of quality engineering experience.
Knowledge of ISO 13485, QSR, ISO 14971, and statistical techniques.
Expertise in design assurance, including design controls, standards compliance, and risk management.
Strong written and verbal communication skills.
Strong organisational skills.
Experience with MDR – advantage.
Experience with IEC 62304 and IEC 62366 – advantage.
Ability to influence and assess situations to determine if a blocking issue is triggered.
Equal Opportunity Employer
Becton, Dickinson and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
Salary
€54,800.00 – €83,600.00 EUR Annual
Location
Limerick, County Limerick, Ireland
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