Sr. Manager, Quality Engineering

We need to output HTML fragment with sections: About the role? The posting includes "Working at Abbott" paragraph, "The Opportunity", "What You'll Work On" with subsections, "Required Qualifications", "Preferred Qualifications", "What Success Looks Like", "What We Offer". Also pay info: "The base pay for this position is $129,300.00 – $258,700.00." So we need a Pay section. We must not repeat job title as heading. Use

for section headings. Use

• for any list of duties/requirements/benefits. Use

  for prose. We must include sections only when posting has real specific content. So we need sections: About the role? The "Working at Abbott" could be About the role? Actually "Working at Abbott" describes company culture and benefits. Could be "About the role" maybe not. But we can create sections: About the role (maybe summarizing the role description). However we must not create filler. The posting includes "The Opportunity" which describes role location and purpose. Could be "About the role". Also "What You'll Work On" includes multiple sub-sections; we could treat each bullet as separate sections? But we need to use headings for sections like Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. The instruction: use

  for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we should map content to these standard headings where appropriate. We need to decide which sections to include based on content. We have: - About the role: could include description of role, location, purpose (The Opportunity). Also maybe "Working at Abbott" is more about company, but could be part of About the role? Probably better to put company overview in About the role? Actually "About the role" is about the job itself. So we can put the description from "The Opportunity" and maybe first paragraph "Working at Abbott" is more about company benefits, but could go under Benefits? However Benefits section is for benefits offered. The posting includes benefits under "What We Offer". So we can put that under Benefits. Thus sections: - About the role: include The Opportunity paragraph(s) describing location, purpose, role responsibilities high-level. - Responsibilities: could be the "What You'll Work On" sections (Quality Strategy & Leadership, Quality Data Analytics & Business Insights, Quality Systems & Compliance, Regulatory & Audit Leadership, Cross-Functional Collaboration, People Leadership). Those are responsibilities. - Requirements: Required Qualifications. - Qualifications: maybe Preferred Qualifications? But we already have Requirements; Qualifications could be Preferred Qualifications. Or we could combine Required and Preferred under Requirements and Qualifications respectively. The instruction list includes both Requirements and Qualifications as possible headings. So we can put Required Qualifications under Requirements, and Preferred Qualifications under Qualifications. - Skills: maybe not explicitly listed; but we could extract skills from Required Qualifications (analytical background, influence stakeholders, communication, presentation, project management). However we should not invent. Better to omit Skills if no explicit skills list. But we could include a Skills section if we can derive from content without inventing? The instruction: "Prefer a few substantive sections over many thin ones." So we could skip Skills if not clearly defined. - Benefits: from "What We Offer" includes list: fast-paced work environment, safety priority, clean production areas, training and career development, tuition assistance, financial security via competitive compensation, incentives, retirement plans, health care and well-being programs (medical, dental, vision, wellness, occupational health), paid time off, 401(k) with match, stability. Also earlier mentions: free medical coverage in HIP PPO, excellent retirement savings plan with high employer contribution, tuition reimbursement, Freedom 2 Save student debt program, FreeU education benefit, company recognized as great place to work, etc. Those are benefits. So we can combine. - Pay: from base pay range. - Schedule: not mentioned, so omit. We must not include boilerplate like EEO, application instructions, cookie/navigation, etc. Remove duplicated lines. We must preserve all substantive information; do not invent or summarize away detail. So we need to keep specifics: e.g., "Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year." etc. We need to format as HTML fragment, using

  for each section heading, then content: either

  for prose, or

  • for lists. We need to decide what to list as
    • . For responsibilities, we have multiple bullet-like sections each with multiple sentences. Could treat each major heading (Quality Strategy & Leadership, etc.) as a
    • with its content as

      inside? Or we could make each responsibility as a

    • with the description as text. The instruction: Use
      • for any list of duties/requirements/benefits. So if we have a list of duties, we should use
        • . For responsibilities we have a list of duty areas. So we can make
          with each duty area as
          • . Inside each
          • we can have

            for the prose. Similarly for Required Qualifications: list of items; we can use

            • . Preferred Qualifications: also list. Benefits: list of items; we can use
              • . Pay: just a

                with the range. About the role: prose

                . We must not repeat job title as heading. So no

                for Senior Manager, Quality Engineering. We must not put Job ID/requisition numbers as headings; none present. We must not include sections with filler like "commensurate with experience". Not present. Now let's extract content precisely. First, About the role: from "The Opportunity" paragraph(s): "The 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." We could keep that as prose. Now Responsibilities: from "What You'll Work On" sections: - Quality 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. We'll put each as

                with

                inside. Now Requirements (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. We'll list as

                • . Now Qualifications (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. Now Benefits: from "What We Offer" plus earlier benefits. Let's extract all benefits mentioned: From earlier "Working at Abbott": - Career development with an international company where you can grow the career you dream of. - Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. - An excellent retirement savings plan with a high employer contribution. - Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. - A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. - A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and