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
As directed by the Associate Director - Quality, the Senior Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance, and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and Business Unit policies while meeting all design control and other regulatory requirements.
Responsibilities:
Provides support/mentoring/coaching for application of technical principles, theories, concepts and quality, tools and systems. Develops technical solutions to complex problems which require the regular use of technical knowledge, experience, ingenuity, and creativity. List a core team member for complex design control / process control projects. Can serve as a CAPA expert.
Modifies methodologies and procedures, ensuring continuous improvement of desired outcomes. Supports quality system audits.
Provides input to the management review process
May perform other duties as required
Scope of Responsibilities
Develops advanced technological ideas and guides their development into a final product, process or business opportunity.
Ensures the accurate and actionable recording of data for the making of decisions as well as to document development work
Contributes to long-range business strategies, choosing disciplines and methods appropriate to the work content and context
Outputs contribute to reduced cycle times, improved effectiveness and furthering the achievement of goals critical to company objectives
Position-Specific Overview
Position specific responsibilities include support of the following, however, are not limited to:
Design Control
EU MDD/MDRl
Change control
Risk Management
Process Validation
Identification of CTQ's
Handling of deviations and non-conformances
Test method validations
Supplier qualification
Post Market Surveillance
CAPA – Root cause investigation and implementation of corrective / preventive actions
Proper Use of Statistics (Sampling Plans)
Advise on Regulations and standards
Liaise with Manufacturing Plants
Provide functional support to cross-functional teams
Support Internal and external audits
Sphere of Influence
Work is performed without appreciable direction.
Assignments are often self-initiated. Determine and pursue courses of action necessary to obtain desired results.
Plans and participates in disciplines strategically relevant to the business and/or functions
Provides advice and mentors junior Associates
Participates in, and may provide leadership for, multi-disciplinary projects
Considered Site / functional level Subject Matter Expert.
May be assigned as site / functional extended team member
Qualifications
Bachelor’s Degree
A minimum of 7 years of relevant experience or a combination of equivalent education and relevant experience
Minimum 5 years of experience supporting design assurance for medical devices
Extensive knowledge of applicable regulatory, Corporate and/or Unit requirements. Applicable Regulatory and Industry standards (21-CFR-820, ISO 13485, MDD, MDR, ISO 14971,ISO 10993, etc.)Quality Engineering tools, Statistics, Problem Solving, strong Interpersonal Skills, Leadership, all forms of Communication
ASQ Certificate(s) desirable (but not required)
Design for Six Sigma preferred
At BD, we prioritize on-site collaboration because we believe it fosters creativity,…