Job Description SummaryAre you ready to make a difference in this world? Do you want to be part of a team that develops ground-breaking medical and biotechnology services and devices? One person can make a singular difference in saving and improving lives. At BD, we are looking for amazing, passionate and dedicated people like you. BD, a company standing on 120 years of innovation in medical technology, is currently recruiting talented individuals to join our new Research and Development (R&D) Centre of Excellence in Limerick.
The QE Manager is responsible for the overall quality engineering of new product development and product maintenance through the application of Quality engineering skills.
You will ensure the supervision of a team of several quality engineers, from product inception through product launch and maintenance utilizing a high level of written and oral communication skills.
Represents the Quality management Function on Project Teams for both new product development and existing products.
Plays an active role in the processes to ensure products meet quality standards consistent with both Corporate and division policies, while meeting all design controls, risk management, change control requirements and other applicable regulatory requirements.
Defines appropriate metrics to measure progress and to define yearly objectives.
This position is also responsible for resolving complex problems and driving quality engineering improvements.
Ensures that the following activities are performed thru project quality engineers’ management
Evaluation of user needs and product requirements to identify applicable quality standards
Ensuring process validation activities are completed appropriately and make the link with product design whenever needed.
Define product control strategy
Evaluation of test methods used in project activities
Review and challenge statistical rationale, plan and data analysis in the frame of test protocol / reports. Assist / conduct Failure investigations and problem-solving sessions
Continue to build Quality Management leadership and technical capability throughout the organization by integrating, aligning, and increasing the rigor of quality engineering processes across the global organization.
What you need for the role:
10 years industry experience (Healthcare/Pharmaceutical/Biologics/Medical Devices)
Experience working with cross-functional teams and remote teams, promote work in multidisciplinary teams
General understanding of Design Control, DFSS
Experience in Quality System, Six Sigma Methodology, Validation, FMEA/Risk Management
Understanding of industry regulations/standards: ISO 13485, QSR, 21CFR820, ISO 60601, 62304, 62336
If you’re a team player who is passionate about Engineering and ‘advancing the world of health’ and we’ve just described your career aspirations, then please click on the APPLY button where you will be directed to our website to apply directly.
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/