Senior Quality Systems Engineer

5 days ago

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

Job Summary:

We are seeking a highly skilled Senior Quality Systems Engineer to join our team at BD (Becton, Dickinson and Company). As a key member of our quality team, you will be responsible for planning and implementing corrective actions (CAPA) to address quality issues, developing and managing quality systems to ensure compliance with regulations and industry standards, and conducting regular audits and inspections to identify areas of improvement and provide recommendations for corrective action.

Responsibilities:

  • Develop and manage quality systems to ensure compliance with regulations and industry standards.
  • Collaborate with cross-functional teams to develop and implement quality control plans, procedures, and protocols.
  • Conduct regular audits and inspections to identify areas of improvement and provide recommendations for corrective action.
  • Monitor product performance and trends to identify potential issues or opportunities for improvement.
  • Investigate customer complaints and provide detailed reports on findings and recommendations.
  • Provide training and support to employees on quality processes and procedures.
  • Stay up-to-date on emerging trends and technologies in quality management and regulatory requirements.
  • Collaborate with external partners such as suppliers, vendors, and regulatory agencies to maintain relationships and communicate quality expectations.
  • Maintain records of all quality activities including documentation, testing results, and nonconformity reports.

Requirements:

  • Bachelor's degree in Engineering, Life Sciences, or related field.
  • Minimum 5 years of experience in quality assurance or similar role within a regulated industry (e.g., medical device, pharmaceutical).
  • Previous experience managing CAPA processes and auditing.
  • Strong understanding of quality management principles, ISO standards, and regulatory requirements (FDA, GMP, etc.) and MDSAP program.
  • Proficiency in quality system software such as SAP QMS, TrackWise, etc.
  • Excellent communication skills both written and verbal.
  • Ability to collaborate effectively across functional teams.
  • Attention to detail and strong organizational skills.
  • Self-motivated and proactive in identifying and resolving problems.
  • Familiarity with statistical analysis techniques and tools.
  • Familiarity with root cause analysis techniques and tools.

Why BD?

At BD, we are committed to investing in our associates' well-being and development, and providing rewards and recognition opportunities that promote a performance-based culture. We offer a competitive package of compensation and benefits programs, and a salary range of $99,163,300.00 USD Annual. If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity.

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