Director – Quality Engineering – Ww Ipd
| Company | Becton Dickinson |
|---|---|
| Location | Brea, CA, USA, San Diego, CA, USA |
| Salary | $179200 – $322500 |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Expert or higher |
Requirements
- Bachelor’s degree in engineering, Life Sciences, or a related field (advanced degree preferred)
- Minimum 15 years of progressive experience in Design Quality Assurance within the medical device industry
- At least 6 years of direct management experience
- Proven experience in New Product Development and Sustaining Engineering
- Strong critical thinking, analytical, and decision-making skills
- Excellent verbal and written communication skills; assertive and collaborative leadership style
- Demonstrated ability to lead cross-functional and cross-regional teams
- Experience managing professional and technical QA staff
- Deep knowledge of global medical device regulations (FDA, EU MDR, etc.)
Responsibilities
- Lead execution of unit-level Quality activities to achieve Business Driver Goals (BDGs), Key Driver Goals (KDGs), and quality performance metrics
- Drive continuous improvement initiatives and develop Quality strategies to enhance product quality and customer satisfaction
- Lead the Quality organization across Design Centers (San Diego, Brea, TCI), supporting compliance, sustaining engineering, new product development, and cost-reduction initiatives
- Accountable for disposable sets to ensure a system-level approach between pumps and sets, including alignment and consistency in risk management files, coordinated change control processes between pumps and sets and oversight of system performance of disposable sets
- Act as the interface between Worldwide IPD and MMS for Design quality assurance, Quality Management System (QMS) alignment and compliance, and Inspection and audit readiness
- Ensure the QMS meets or exceeds applicable regulatory requirements and industry standards
- Establish and maintain a Quality organizational structure that delivers excellent service and optimizes resource utilization
- Provide technical support for Post-Market Quality, including complaint investigations and situation analyses
- Deliver key inputs for IPD Management Reviews and ensure adherence to BD policies and procedures
- Support manufacturing sites with change control processes and problem-solving expertise to mitigate risks
- Develop and coach Quality team members, ensuring continuous improvement and capability development
- Keep senior leadership informed of quality performance and risk across the platform
- Lead Risk Management activities in compliance with ISO 14971 for products under design authority
- Serve as a member of the WW IPD Quality Leadership Team and actively participate in Quality Management Reviews (QMRs)
- Contribute to Quality budget planning, resource allocation, and administration
- Support the Corrective and Preventive Action (CAPA) process
- Lead a team of Quality Managers and Engineers, operating with a high degree of autonomy
- Initiate and lead cross-functional, strategic projects relevant to the business
- Act as a subject matter expert (SME) at the site and functional level
Preferred Qualifications
- ASQ certification (Engineer or Manager) preferred
- Six Sigma Green Belt or Black Belt certification preferred
- Experience in manufacturing, project management, or engineering is a plus
- International experience and ability to manage global teams and stakeholders