Senior Quality Engineer – Design Assurance
BD is one of the largest global medical technology companies in the world. We advance the world of health through design, engineering, manufacturing and marketing of MedTech products.
Job Description
As Design Assurance Quality Engineer you will be involved in new product development and product sustaining projects through the application of quality engineering skills. You will handle multiple projects and tasks from product inception through product launch and maintenance, utilising a high level of written and oral communication skills.
You will play an active role in processes to ensure products meet quality and compliance standards consistent with both corporate and global standards and regulations, while meeting design controls, risk management, change control and other applicable regulatory requirements. The Design Assurance QE 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 protocol and reports.
Review and challenge statistical rationale and data analysis in the frame of test protocol 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 organisation while providing training on applicable requirements / standards.
Qualifications
A relevant degree (engineering degree preferred) or equivalence of minimum 3 years of quality engineering experience.
Knowledge in working with ISO 13485, QSR, ISO 14971, statistical techniques.
Strong written and verbal communication skills.
Strong organisational skills.
Experience with MDR – advantage.
Experience with IEC 62304 and IEC 62366 – advantage.
Salary
Salary Range 55 K – 70 K.
Location
Primary Work Location: IRL Limerick – Castletroy.
Equal Opportunity Statement
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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