JOB DESCRIPTION:The OpportunityThe Director, Global Post Market Quality & Returns Laboratories provides strategic and operational leadership for Abbott's Cardiac Rhythm Management (CRM) post-market quality organization. This role is responsible for global complaint handling, returned product investigation and analysis, post-market surveillance, and quality trend monitoring to ensure ongoing product safety, regulatory compliance, and continuous product improvement.
Leading a global organization of approximately 140 professionals through 3-4 direct reports, the Director drives excellence across complaint management processes, return product evaluation laboratories, and post-market quality systems. This position serves as a key leader in leveraging customer and product performance data to identify risks, drive product and process improvements, and ensure compliance with evolving global regulatory requirements.
The Director partners closely with Quality, Regulatory Affairs, R&D, Manufacturing, Medical Affairs, and Commercial organizations to strengthen product quality, enhance customer experience, and support business objectives.
What You'll Work OnStrategic Leadership & Post-Market Quality Oversight:
- Lead the global Post Market Quality organization, including complaint handling operations and two post-market returns laboratories, ensuring effective execution of product surveillance, investigations, and regulatory reporting activities.
- Establish and execute the strategic vision for post-market quality systems, leveraging emerging technologies, data analytics, and automation to improve efficiency, compliance, and customer insights.
- Drive continuous improvement initiatives that enhance complaint management effectiveness, product return analysis, and overall quality system performance.
- Ensure robust monitoring and analysis of post-market data to identify emerging product trends, quality signals, and patient safety concerns.
Complaint Handling & Product Surveillance:
- Provide executive oversight for global complaint investigations, ensuring timely and compliant evaluation, documentation, escalation, and closure of customer complaints.
- Direct the assessment of complaint and returned product data to identify systemic quality issues, product performance trends, and opportunities for risk mitigation.
- Ensure effective implementation of post-market surveillance processes that support global regulatory reporting requirements and product monitoring obligations.
- Lead cross-functional reviews of complaint and product performance trends to drive proactive risk management and quality improvement actions.
Product Returns Laboratories:
- Oversee operation of post-market returns laboratories responsible for evaluation, testing, and analysis of returned products.
- Ensure scientifically sound, data-driven assessments are conducted to support quality investigations, regulatory reporting, and product improvement initiatives.
- Drive laboratory modernization efforts through implementation of tools, metrics, and enhanced operational capabilities.
Quality Risk Management & Compliance:
- Provide leadership and governance for investigation and disposition of high-risk product nonconformance and post-market quality events.
- Ensure comprehensive root cause investigations, corrective actions, and preventive actions (CAPA) are implemented and sustained to prevent recurrence.
- Partner with Regulatory Affairs and Quality leadership to maintain compliance with FDA regulations, international quality system requirements, and global medical device regulations.
- Assess the impact of evolving regulatory requirements and implement organizational changes to ensure ongoing compliance.
Regulatory & External Agency Engagement:
- Serve as the primary quality representative during inspections, audits, and interactions with regulatory agencies, including FDA, international Ministries of Health, Notified Bodies, and other government authorities.
- Lead preparation and response activities related to regulatory inspections, inquiries, compliance actions, and post-market surveillance requirements.
- Communicate quality risks, trends, and remediation strategies to senior leadership and regulatory stakeholders.
Business & Financial Leadership:
- Develop and manage departmental budgets, resource planning, and capital investments to support business objectives.
- Lead productivity and cost-efficiency initiatives that contribute to divisional operating margin improvement while maintaining product quality and regulatory compliance.
- Establish operational performance metrics and drive accountability for achieving quality, compliance, financial, and customer-focused objectives.
Talent & Organizational Leadership:
- Lead, develop, and inspire a high-performing global organization of approximately 140 employees through 3-4 direct reports.
- Build organizational capability through succession planning, talent development, leadership coaching, and workforce planning initiatives.
- Foster a culture of quality, accountability, continuous improvement, innovation, and employee engagement.
- Develop future leaders and strengthen organizational readiness for evolving business and regulatory challenges.
Required Qualifications- Bachelor's degree in Engineering, Life Sciences, Quality, Biomedical Sciences, or a related technical discipline.
- Minimum of 10 years of progressive experience within the medical device, pharmaceutical, biotechnology, or other FDA-regulated industry.
- Significant leadership experience managing quality, compliance, post-market surveillance, complaint handling, or related quality system functions.
- Experience leading a larger organization and developing high-performing teams.
- Demonstrated knowledge of global regulatory requirements, including FDA Quality System Regulations and international medical device regulations.
- Experience managing regulatory inspections and interactions with government agencies and regulatory authorities.
- Proven ability to lead cross-functional initiatives, influence senior stakeholders, and drive organizational change.
APPLY NOWLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
The base pay for this position is $172,000.00 - $344,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Operations Quality
DIVISION:CRM Cardiac Rhythm Management
LOCATION:United States > Sylmar : 15900 Valley View Court
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:Yes, 20 % of the Time
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Keyboard use (greater or equal to 50% of the workday)
