JOB DESCRIPTION:Senior Manager, Quality EngineeringThe Opportunity This position works out of our St Paul MN OR Plymouth, MN location for our Electrophysiology business. In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.
We are seeking a strategic and influential
Senior Manager, Quality Engineering & Analytics to lead quality systems performance, quality data analytics, and continuous improvement initiatives across the organization. This leader will be responsible for transforming quality data into actionable business insights, driving compliance, and building a long-term vision for how quality data can be leveraged to improve product performance, patient safety, and business outcomes.
This role goes beyond traditional quality management. The successful candidate will lead a team responsible for analyzing and integrating data from complaints, CAPA, management reviews, post-market surveillance, quality metrics, manufacturing performance, and commercial data to identify trends, mitigate risk, and shape future-state quality strategies.
The ideal candidate combines strong quality leadership experience within the medical device industry with a passion for analytics, systems improvement, and organizational influence.
What You'll Work OnQuality Strategy & Leadership- Provide strategic leadership and oversight for Quality Engineering and Quality Analytics functions.
- Establish a vision for the future of quality data management, analytics, and reporting capabilities across the business.
- Lead the development and execution of quality strategies that support product quality, patient safety, compliance, and operational excellence.
- Serve as a key member of the quality leadership team, influencing business decisions through data-driven insights.
- Build organizational capability by coaching, mentoring, and developing high-performing quality professionals.
Quality Data Analytics & Business Insights- Lead the collection, analysis, interpretation, and presentation of quality performance data across the organization.
- Oversee management reviews, monthly quality reviews, complaint trending, CAPA effectiveness monitoring, post-market data analysis, and key quality performance indicators.
- Integrate data from manufacturing, commercial sales, complaints, risk management, and quality systems to identify emerging trends and opportunities.
- Develop executive-level dashboards and reporting that provide clear visibility into product quality and business performance.
- Drive continuous improvement of reporting systems, automation tools, and analytics capabilities.
- Create a roadmap for future-state quality analytics capabilities, leveraging data to proactively identify and mitigate risks.
Quality Systems & Compliance- Ensure manufacturing quality system requirements are effectively established, maintained, and continuously improved.
- Monitor and report quality system performance to executive leadership.
- Lead quality system reviews and ensure compliance with applicable domestic and international regulations.
- Provide oversight of CAPA processes, complaints management, nonconformance management, and quality system effectiveness.
- Drive proactive compliance initiatives across quality operations and business functions.
- Lead initiatives to improve quality processes, procedures, and automated quality systems.
Regulatory & Audit Leadership- Serve as a primary quality representative during external regulatory inspections and audits.
- Ensure readiness for FDA, notified body, and international regulatory inspections.
- Partner with Regulatory Affairs, Manufacturing, Engineering, and Operations leadership to address compliance risks and regulatory requirements.
- Ensure quality activities comply with FDA regulations, ISO 13485, and other applicable global standards.
Cross-Functional Collaboration- Partner with Manufacturing, Engineering, Product Development, Regulatory Affairs, Risk Management, Clinical, and Commercial teams to drive business outcomes.
- Influence senior stakeholders and cross-functional leaders to implement quality improvements and risk mitigation strategies.
- Lead enterprise-level quality initiatives across functions, sites, and business units.
- Translate complex quality data into meaningful business recommendations that drive action.
People Leadership- Recruit, develop, and retain diverse, high-performing teams.
- Establish performance goals aligned with organizational objectives.
- Foster a culture of accountability, collaboration, innovation, and continuous improvement.
- Provide ongoing coaching and career development for team members.
- Create an environment focused on patient safety, quality excellence, and business partnership.
Required Qualifications- Bachelor's degree in Engineering, Science, Quality, or related technical discipline.
- 10+ years of progressive experience in Quality Engineering, Quality Systems, Quality Assurance, or related functions within the medical device or highly regulated industry.
- 5+ years of people leadership experience managing technical or quality teams.
- Demonstrated experience leading quality systems and quality compliance programs in Class II or Class III medical device environments.
- Experience with complaint handling, CAPA management, management reviews, quality metrics, and post-market quality systems.
- Strong analytical background with experience leveraging data to drive business decisions.
- Knowledge of FDA Quality System Regulations (21 CFR Part 820), ISO 13485, GMP requirements, and global quality standards.
- Proven ability to influence stakeholders and lead cross-functional initiatives in a matrixed environment.
- Exceptional communication, presentation, and executive stakeholder management skills.
- Strong project management and organizational leadership capabilities.
Preferred Qualifications- Advanced degree in Engineering, Quality, Data Analytics, Business, or related field.
- Experience building or modernizing quality analytics platforms, dashboards, and automated reporting systems.
- Knowledge of statistical methods, data visualization tools, and quality data management systems.
- ASQ Certifications (CQE, CQA, CMQ/OE) preferred.
- Six Sigma Green Belt, Black Belt, or equivalent continuous improvement certification.
- Experience supporting global quality operations and multi-site organizations.
- Experience working closely with commercial and post-market surveillance teams to connect customer feedback with quality strategy.
What Success Looks LikeIn this role, you will:
- Establish a clear vision for the future of quality analytics and data-driven decision making.
- Transform quality, complaint, CAPA, and manufacturing data into proactive business intelligence.
- Identify emerging quality risks before they impact customers or patients.
- Strengthen management review processes through meaningful, actionable insights.
- Develop a high-performing team that is viewed as a strategic business partner.
- Enhance compliance while driving operational efficiency and continuous improvement.
- Influence senior leadership through clear communication of quality performance and risk.
What We OfferAt Abbott, you can have a good job that can grow into a great career. We offer:
- A fast-paced work environment where your safety is our priority
- Production areas that are clean, well-lit and temperature-controlled
- Training and career development, with onboarding programs for new employees and tuition assistance
- Financial security through competitive compensation, incentives and retirement plans
- Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
- Paid time off
- 401(k) retirement savings with a generous company match
- The stability of a company with a record of strong financial performance and history of being actively involved in local communities
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 $129,300.00 - $258,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Operations Quality
DIVISION:EP Electrophysiology
LOCATION:United States > Minnesota > St. Paul > Tech Center : One St Jude Medical Drive
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:No
MEDICAL SURVEILLANCE:No
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
