Job Title: Design Quality Engineer
About the Role:
We are seeking a highly skilled Design Quality Engineer to join our team at BD Medical. The successful candidate will be responsible for ensuring that new product designs and manufacturing processes meet all local, corporate and divisional requirements with respect to safety and efficacy.
Main Responsibilities:
* Represent quality interests and concerns on project teams.
* Lead risk management activities and own the Quality engineering activities for NPD projects.
* Balance multiple projects and tasks, from product inception through product launch and maintenance.
* Review design control compliance requirements for NPD projects and all design elements.
* Develop UFMEA & DFMEA, coordinate guidance from other design sub-team members and support PFMEA development.
* Perform DOE's and other statistical analysis to support product and process optimization or resolve causes of process variation.
* Initiate corrective actions as required.
* Support assessment of biocompatibility testing required as per ISO10993 and company procedures.
* Participate in internal audit and supplier audit programs.
* Risk management - U/DFMEA; Risk Analysis, Risk Management File and Gauge R&R and Test Method Validation.
About You:
* Third-level Engineer / Technical / Science Qualification
* Minimum of 5 years in the medical device or pharmaceutical industry desirable
* Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971 and CMDR
* Attention to detail and adaptability
* Dedication to excellence, flexibility
* Problem-solving techniques with excellent organization skills
* Excellent interpersonal skills with ability to work in a team environment and work under own initiative to target and deadlines
Our Vision:
At BD, we collaborate on a large scale, focusing on making sure everything is correct, effective and efficient to bring the highest-quality and most competitive products and services to our customers and their patients.
About Us:
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.