Quality Engineer l – Complaint Management

Overview

Quality Engineer I – Complaint Management:
This position supports and provides oversight of product complaint investigations and Post Market Surveillance activities.

• 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 risked 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, including CID creation, C Chart commentary, and ESDS analysis/evaluation
• Quality engineering representation on Product Development Teams related to complaints
• Participate in project planning, scheduling, and tracking
• Comply with company procedures and policies, and government regulations
• Other duties and projects as assigned

• BS in Engineering or relevant field
• Understanding of how products are used and their impact on users 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 experience
• 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 and qualifications for this position. It is not inclusive of all duties an individual might be asked to perform or all qualifications that may be required now or in the future. For certain roles at BD, employment is contingent upon proof of full COVID-19 vaccination where required by location, and some locations may require testing.

Accommodation requests will be considered pursuant to applicable laws.

A career at BD means being part of a team that values your opinions and contributions and encourages you to bring your authentic self to work. We help each other be great, do what’s right, hold each other accountable, and learn and improve every day. To learn more, visit BD careers at the provided link in the original posting.