Quality Engineer l – Complaint Management

Job Description Summary

This position supports and provides oversight of product complaint investigations and Post Market Surveillance activities.

We are the makers of possible

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 Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

• Technical leadership skills including an understanding of medical device operations (e.g., medical device manufacturing, process development, quality assurance)
• Oversight and support complaint investigations
• Sampling of complaint investigations completed by supplier
• Ability to make and present risk‑based decisions
• Support the development and revision of reportability guidelines
• Support internal and external supplier audits
• Provide support to Post Market Quality in responding to additional information requests from regulatory agencies
• Develop and implement procedures to comply with corporate and industry standards
• Support the evaluation of returned complaint devices through training, developing test methods, and leading equipment qualifications
• Support and/or lead CAPA activities associated with product complaints
• Provide monthly analysis of complaint data for assigned products, i.e., CID creation, C Chart commentary, ESDS analysis/evaluation
• Quality engineering representation (complaint related) on Product Development Teams
• Participate in project planning, scheduling, and tracking
• Complies with company procedures and policies, government regulations
• Other duties and projects, as assigned

• BS in Engineering or relevant field
• Knows how products are used and impact the user(s) so that risk can be managed effectively
• Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.)
• Ability to support the creation/revision of risk management files
• Ability to develop solutions with business impact
• Statistical and risk assessment techniques
• Strong interpersonal skills

• Working knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies
• Ability to make and present risk‑based decisions
• Ability to analyze and optimize manufacturing and quality systems
• Product, design & prototyping
• Ability to create and provide training
• Problem solving ability
• Ability to create, review and coordinate test protocols and reports
• Ability to generate engineering proposals
• Oral and written presentation skills
• Ability to participate on cross functional teams
• Understanding of regulatory requirements including ISO 13485, ISO 14971

While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.

While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team‑oriented, fast‑paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be…