Senior Quality Assurance Engineer

2 weeks ago

San Diego, California, United States BD (Becton, Dickinson and Company) Full time

Job Overview

The Senior Quality Assurance Engineer plays a pivotal role within the New Products Development Team, overseeing quality assurance-related research and development activities from initial research to product launch. This role is crucial in ensuring that quality engineering principles are effectively integrated into both new product development and ongoing engineering projects.

Key Responsibilities

  • Act as the primary quality representative for design control initiatives in new product development and ongoing projects.
  • Oversee all quality-related aspects of the design control process, including quality planning, verification and validation planning and execution, risk management, and regulatory compliance support.
  • Provide guidance and clarification to teams regarding the overall quality system, with a focus on design controls.
  • Collaborate closely with Program Managers to ensure that design deliverables are achieved and ready for limited or general release.
  • Work alongside Quality Engineers to ensure thorough verification of design specifications and requirements.
  • Monitor daily activities to ensure adherence to company policies and procedures, including compliance with quality management systems and relevant medical device regulations.
  • Identify opportunities for quality enhancement and initiate action plans for implementation.
  • Participate actively in the development of product requirements, hazard analysis, and design reviews.
  • Engage proactively with partners to foster consensus and resolve issues promptly.
  • Provide statistical support and analytical problem-solving expertise for product development and manufacturing.
  • Ensure that product technical files and Design History Files are comprehensive and auditable.
  • Drive continuous improvement initiatives by facilitating collaboration with cross-functional teams.

Qualifications for Success

  • Strong understanding of quality engineering policies, principles, and best practices.
  • Familiarity with regulatory and international standards, including 21 CFR 820, ISO 13485, and ISO 14971.
  • Comprehensive knowledge applicable throughout the product development lifecycle.
  • Experience with hardware, software, and firmware development processes.
  • Ability to identify risks and collaborate with program teams to document and mitigate them effectively.
  • Proficient in applying Quality Engineering tools and methodologies such as Sampling Plans and Root Cause Analysis.
  • Ability to work independently with minimal supervision and manage personal work priorities.
  • Act as a resource for less experienced colleagues.

Educational Background

  • Bachelor's degree in engineering or life sciences.
  • A minimum of 10 years of experience focusing on design and development, Quality Engineering, and medical device design controls.
  • Preferred experience in software and hardware development within a medical device context.
  • Attention to detail and strong organizational skills.
  • Ability to work proactively and manage multiple tasks efficiently.
  • Excellent verbal communication and interpersonal skills.
  • Proficiency in Excel, Word, and other business systems.
  • Preferred certifications include Six Sigma and Quality Engineering Certification (ASQ) or equivalent.

Company Commitment

At BD, we are dedicated to fostering a workplace that values your contributions and encourages personal growth. We strive to create an environment where you can thrive and find fulfillment in your role, contributing to the advancement of health globally.

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