Quality Engineer - Design Assurance

IrishJobs

Limerick, Wexford, Ireland

Limerick, Wexford, Ireland

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About

We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. Job Description 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 be able to handle multiple projects and tasks, from product inception through product launch and maintenance utilizing a high level of written and oral communication skills. Plays an active role in the processes to ensure products meet quality and compliance standards consistent with both Corporate and global standards and 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 will include: 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. About you: 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. The Salary Range Information: €55,000 - €65,000 Click on apply if this sounds like you! At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. 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.

TLNT1_IJ

Limerick, Wexford, Ireland

Languages

English

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