BD (Becton, Dickinson and Company) Senior Quality Engineer - Design Assurance in Dún Laoghaire, Ireland
Job Description Summary
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BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 75,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
Reporting to the Senior Manager, Quality Engineering for the Franklin Lakes design center, the Senior Quality Engineer for the Wearable Injector platform is responsible for supporting design control activities; responsible for problem-solving approaches and analytical skills to support new product development and product maintenance using quality engineering skills including but not limited to process validation, measurement system analysis, root cause analysis.
The position ensures all design control and production/ process control projects meet applicable regulatory (local and international), corporate and unit requirements. requires the ability to handle multiple projects, from product inception through product launch and maintenance. In addition, this position will play an active role in the processes to ensure products meet quality standards consistent with both corporate and unit policies, while meeting all design control and other regulatory requirements.
Assist/conduct Failure Investigations and problem-solving sessions for non-conforming products
Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods process validation, etc.
Contributes to the completion of specific programs and projects
Independently determines and develops approach to solution
May provide guidance and work direction to other team members
Liaise with Manufacturing Plants
Provide functional support to cross-functional teams
Define product control strategy
Lead risk management activities
Ensure design control elements are satisfied
Ensure/ perform process validation activities
Support supplier qualification activities – risk classification assessment and product quality assessments
Evaluate test methods used in project activities
Evaluation of customer requirements to identify applicable quality standards
Release product (customer samples) during development activities
Realization of quality functional reviews
Ensure implementation of Pharmaceutical Systems global procedures and standards for QE engineering activities
Provide support to internal, regulatory body and customer audits and associated corrective actions.
Supports continuous improvement of current products and practices to improve quality, customer experience, and worldwide market share
Support new customer onboarding activities – pre-feasibility and feasibility work
Education and Experience:
Minimum of 5 years of relevant experience (Medical Device/ Pharmaceutical)
BS degree in Engineering, or other scientific discipline.
Good understanding of Statistical Methods for Quality Assurance
General working knowledge of the six-sigma process methodology
Thorough understanding of industry regulations: QSR/cGMP, ISO QM standards
Good written and oral communication skills
Excellent problem solving and analytical skills
Ability to handle multiple projects simultaneously in an unsupervised environment
Ability to thoroughly evaluate, clearly understand and communicate all aspects of assigned project.
You can look forward to a rewarding career, great benefits package, collaborative working and opportunities to expand your skills in this fast moving, dynamic and agile business.
If you’re a team player who is passionate about healthcare and we’ve just described your career aspirations, then please click on the APPLY button.
Interested in a career with BD, but this position doesn’t fit your skills and experience? Join our external EMEA Talent Community here: https://emea.jobs.bd.com/
Primary Work Location
IRL Dun Laoghaire - Pottery Road