Posted: 16 June
The role
About the Job
The Design Assurance QE is involved in new product development and product sustaining projects through the application of Quality engineering skills.
Must handle multiple projects and tasks, from product inception through launch and maintenance using strong written and oral communication skills.
Play an active role in ensuring products meet quality and compliance standards consistent with corporate and global regulations while meeting all design controls, risk management, change control requirements, and other applicable regulatory requirements.
Represents the Quality Function on project core teams for both new product development and existing products.
Main Responsibilities
Be the Design Assurance Quality Engineer on project core teams for design change projects and develop close relationships with other quality functions as needed for the project.
Write project quality plans and support the creation and maintenance of DHF documentation.
Lead risk management activities within the project.
Support the creation and implementation of verification and validation activities.
Review and approve test protocols and reports.
Review and challenge statistical rationale, and data analysis in the frame of test protocols and reports.
Review and approve related execution deviations.
Assist / conduct failure investigations and problem‑solving sessions.
Review quality objectives and goals that have been identified and ensure they are sufficiently defined in specifications, procedures, and testing.
Conduct quality functional reviews and DHF compliance reviews.
Ensure compliance across projects for design control, risk management, and change control processes.
Support Quality culture within R&D organization while providing training on applicable requirements / standards.
Qualifications
Completed a level 8 Engineering Degree in a relevant subject.
3+ years experience within a quality engineering environment.
Knowledge in working with ISO 13485, QSR, ISO 14971, statistical techniques.
Strong written and verbal communication skills.
Strong organisational skills.
Experience with IEC 62304 and IEC 62366 – advantage.
Salary Range
€55,000 - €65,000
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.
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