Senior Quality Engineer - Design Assurance
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.
Responsibilities will span from product inception through launch and maintenance, requiring strong collaboration with cross‑functional teams and effective communication skills. You will lead risk management activities, manage Design History File (DHF) documentation, support compliance initiatives such as IEC 60601 and IEC 62304, review and approve verification and validation plans, challenge statistical rationales, authorize deviations, assist in failure investigations, track software issues, and advocate a strong quality culture.
Main Responsibilities Will Include
Be the Design Assurance Quality Engineer on project core teams for design change projects and build close relationships with core team members.
Contribute to formation and ongoing management of DHF documentation.
Lead risk management activities within the project.
Drive compliance management activities such as IEC 60601 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 test protocols and reports.
Assess and authorize related execution deviations.
Assist or conduct failure investigations and problem‑solving sessions.
Responsible for the software issue tracking process per IEC 62304 to ensure software 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 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 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 blocking issues.
Salary Range: €54,800.00 – €83,600.00 EUR Annual.
BD 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 status, familial status, sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
To learn more about BD visit https://bd.com/careers.
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