Senior Quality Systems Engineer

5 days ago


San Diego, California, United States BD Full time

Job Summary:

We are seeking a highly skilled Senior Quality Systems Engineer to join our team at BD. As a key member of our quality assurance team, you will be responsible for planning and implementing corrective actions (CAPA) to address quality issues, including developing and managing quality systems to ensure compliance with regulations and industry standards.

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.


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