Senior Quality Engineer - CAPA
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Job Description
Position Summary
The Senior Quality Systems Engineer – CAPA & Continuous Improvement serves as a subject matter expert (SME) for Quality Systems with primary responsibility for the Corrective and Preventive Action (CAPA) process. This role is responsible for driving CAPA effectiveness, improving quality system performance, and ensuring compliance with applicable regulatory requirements and company standards.
The successful candidate will provide technical guidance, coaching, analytics, and continuous improvement support across the organization while partnering with cross-functional teams to ensure quality issues are effectively investigated, corrective actions are implemented, and quality system processes continue to improve. This position also serves as a key resource for Quality Systems requirements, root cause analysis, compliance initiatives, and quality performance reporting.
Key Responsibilities
CAPA Leadership & Quality Systems
- Serve as the Subject Matter Expert (SME) for CAPA processes across the organization.
- Provide guidance and coaching on investigations, root cause analysis methodologies, corrective actions, CAPA documentation, and effectiveness verification activities.
- Monitor CAPA performance and ensure corrective action plans are completed accurately, effectively, and on time.
- Analyze process nonconformances and support the development and implementation of corrective and preventive actions.
- Provide leadership and support for the timely communication and escalation of significant CAPA-related issues to Quality Leadership and Business Unit leaders.
- Collaborate with Post Market Quality to ensure timely completion of nonconformance escalation activities and Situation Analysis reviews.
- Apply Quality Systems principles including CAPA, document control, and related quality processes to support business objectives.
- Provide work direction, mentoring, and support to CAPA owners and project teams as needed.
Data Analytics & Reporting
- Perform data analysis related to CAPA and Quality Management System (QMS) performance to identify trends, risks, and improvement opportunities.
- Develop, maintain, and present quality metrics, KPIs, dashboards, and reports for management and senior leadership.
- Utilize statistical tools and methodologies, including Six Sigma, Statistical Process Control (SPC), and Design of Experiments (DOE), to evaluate process effectiveness and support data-driven decision-making.
- Support CAPA effectiveness verification activities through statistical analysis, sampling methodologies, and objective evidence.
- Deliver timely and meaningful reports to senior leadership regarding quality system performance and compliance.
Continuous Improvement
- Champion continuous improvement initiatives that enhance quality system effectiveness, compliance, and operational performance.
- Collaborate with CAPA stakeholders across multiple sites to standardize best practices and drive global process improvements.
- Influence cross-functional teams to adopt consistent methodologies, processes, and quality tools across the organization.
- Implement improvements to quality systems, processes, and documentation to increase efficiency and effectiveness.
- Support innovation and quality excellence through the application of data-driven problem-solving methodologies.
Compliance & Quality Programs
- Support the development, maintenance, and continuous improvement of quality programs to ensure compliance with company policies, regulatory requirements, and industry standards.
- Create, review, revise, and approve Quality System documentation.
- Ensure compliance with approved quality methods, Good Documentation Practices (GDP), and quality system procedures.
- Assist with internal audits, external audits, regulatory inspections, and resolution of associated findings.
- Support post-market surveillance activities and quality-related projects as assigned.
- Represent the Quality organization professionally during internal and external interactions.
- Participate in industry and professional organizations as appropriate.
- Assist with special projects and perform other duties as assigned.
Required Qualifications
- Bachelor's degree in Engineering, Engineering Technology, Science, or a related technical field.
- Minimum of 6 years of engineering, quality, or quality systems experience.
- Strong understanding of quality systems regulations and standards, including:
- ISO 9001
- ISO 13485
- FDA Quality System Regulations (QSR)
- EU MDR
- Experience working within regulated industries such as medical device, pharmaceutical, biotechnology, or similar environments.
- Ability to work effectively in a team-oriented environment and deliver on cross-functional objectives.
- Experience owning or managing Quality System processes, particularly CAPA.
Preferred Qualifications
- Experience driving process, product, or quality system improvements.
- Experience with TrackWise or similar electronic Quality Management Systems (eQMS).
- ASQ Certification (CQE, CSQE, CQA, or related certification).
- Lean Six Sigma Green Belt or Black Belt certification.
Knowledge & Skills
- Experience with electronic CAPA management systems (eCAPA).
- Experience managing CAPA processes in regulated industries such as medical devices, pharmaceuticals, or biotechnology.
- Strong root cause analysis and problem-solving skills.
- Advanced Microsoft Excel capabilities, including Pivot Tables, charts, reports, queries, and data analysis.
- Strong applied statistics knowledge and experience using statistical tools to improve process capability and support quality investigations.
- Understanding of sampling methodologies used for CAPA effectiveness verification.
- Strong understanding of auditing principles and quality compliance requirements.
- Ability to analyze complex data and translate findings into actionable recommendations.
- Ability to present data and recommendations effectively to senior leadership.
- Extensive knowledge of Quality Management Systems and cross-functional business relationships.
- Excellent communication, collaboration, and influencing skills.
- Strong organizational and project management capabilities.
- Ability to work independently while effectively partnering with stakeholders across all levels of the organization.
What Makes You Successful
- Ability to lead and influence quality improvements without direct authority.
- Strong analytical mindset with a passion for solving complex quality issues.
- Commitment to continuous improvement and operational excellence.
- Ability to coach and mentor others on CAPA, investigations, and quality system requirements.
- Strong attention to detail and commitment to compliance.
- Collaborative approach to working across functions, sites, and leadership teams.
Why Join Us?
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visit https://bd.com/careers.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
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