Senior Quality Engineer – Design Assurance
BD (Tissuemed Ltd) invites applications for the Senior Quality Engineer – Design Assurance role.
As a Design Assurance Quality Engineer (QE), you will act as the Quality representative on project core teams, overseeing design controls, risk management, and change control processes to ensure new product development and sustaining projects meet stringent quality and compliance standards.
About The Role
You will be involved from product inception through launch and maintenance, managing Design History File (DHF) documentation, leading risk management activities, supporting compliance initiatives such as IEC ***** and IEC *****, reviewing verification and validation plans, authorizing deviations, assisting in failure investigations, tracking software issues, and contributing to broader QMS activities including CAPA, field assessments, and operational engineering evaluations.
Main Responsibilities
Serve as the Design Assurance QE on project core teams for design change projects.
Contribute to the formation and ongoing management of DHF documentation.
Lead risk management activities within the project.
Drive compliance management activities (e.g., IEC *****) 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 authorise related execution deviations.
Assist and conduct failure investigations and problem-solving sessions.
Manage software issue tracking per IEC ***** 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.
About You
Relevant degree or equivalent experience (engineering degree preferred) or a minimum of 5 years of quality engineering experience.
Knowledge of ISO *****, QSR, ISO ***** 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 ***** and IEC *****—advantage.
Ability to influence, assess situations and determine when a blocking issue is triggered.
Benefits & Compensation
Salary range: €54,******–€83,****** EUR per annum.
Employment Information
Location: IRL Limerick – Castletroy.
Employment type: Full-time.
Seniority level: Mid-Senior.
Equal Opportunity Employer
BD, Dickinson & Company is an Equal Opportunity Employer.
We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, citizenship, marital or civil union status, familial status, sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
#J-*****-Ljbffr