Job Description Summary

Develop and sustain quality system CAPA and processes for the Design Center that comply with applicable regulations and standards, Corporate and Business Unit policies and procedures. Identify gaps in existing practices against the procedures and close those gaps.

Job Description

We are the makers of possible 

 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Job Summary:
As a Sr. Quality Systems Engineer, you will be responsible for planning and implementing corrective actions (CAPA) to address quality issues including and developing and managing quality systems to ensure compliance with regulations and industry standards. Additionally, you will conduct 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.

• Investigating and analyzing: Identifying and investigating product and quality issues, and determining root causes 

• Implementing corrective actions: Planning and implementing corrective and preventive actions (CAPA) to address quality issues 

• Documenting and reporting: Maintaining records of investigations, findings, and corrective actions, and preparing reports for management review 

• Collaborating: Working with cross-functional teams to resolve issues and develop CAPAs 

• Communicating: Communicating with stakeholders at all levels, including management, peers, and key stakeholders 

• Supporting training: Supporting the delivery and oversight of CAPA training programs 

• Supporting audits: Providing subject matter expertise during audits and inspections 

• Supporting process improvement: Leading and contributing to continuous improvement initiatives and projects 

Qualifications:

• 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.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Acc