Senior Quality Assurance Engineer

2 weeks ago

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

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

Key Responsibilities:
  • Act as the primary quality representative for design control initiatives, encompassing both new product development and sustaining projects.
  • Oversee all quality dimensions of the design control process, including quality planning, verification and validation strategies, 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 in conjunction with Quality Engineers to ensure effective 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 actionable plans for improvement.
  • Participate actively in the development of product requirements, hazard analyses, and design reviews.
  • Engage proactively with partners to foster consensus and resolve issues promptly.
  • Provide statistical analysis and problem-solving expertise to support product development and manufacturing processes.
  • Ensure that product technical files and Design History Files are thorough and ready for audits.
  • Lead continuous improvement initiatives by facilitating collaboration among cross-functional teams.

Qualifications:
  • 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.
  • Experience in software and hardware development within a medical device context is preferred.
  • Comprehensive understanding of risk management and quality by design principles is advantageous.
  • Strong attention to detail coupled with excellent organizational skills.
  • Ability to work independently and proactively.
  • Proficient in managing multiple tasks efficiently.
  • Exceptional verbal communication and interpersonal skills, with a capacity to work effectively in a team setting.
  • Proficiency in Microsoft Excel, Word, and other business software.
  • Six Sigma certification is preferred.
  • Quality Engineering Certification (ASQ) or equivalent is preferred.

Why Consider This Opportunity?

A career with BD means joining a team that values your insights and contributions, fostering an environment where you can be your authentic self. It’s a place where collaboration is encouraged, accountability is upheld, and continuous learning is a shared goal. At BD, you will find a culture that supports your growth and allows you to make a meaningful impact in the healthcare sector.

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