CAPA Systems Engineer, Senior Staff

SUMMARY: Provides senior-level Quality Systems leadership as the primary subject matter expert for the Corrective and Preventive Action (CAPA) process within a medical device manufacturing environment. Leads complex and high-risk CAPA investigations, ensures compliance with applicable regulatory requirements and internal procedures, and drives systemic improvements to product quality, process capability, and quality system effectiveness. Serves as a strategic technical resource for cross-functional teams, mentors CAPA owners and Quality personnel, and represents CAPA processes during internal, customer, Notified Body, and regulatory audits. Operates with a high degree of independence, using expert judgment, risk-based decision-making, and advanced problem-solving methods to resolve complex quality issues and strengthen the overall Quality Management System.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.Serve as the senior subject matter expert and process owner delegate for the CAPA process, ensuring consistent execution in accordance with applicable regulations, standards, and internal Quality Management System requirements.Lead and facilitate complex CAPA investigations associated with audit findings, nonconformances, complaints, process deviations, supplier issues, field performance, and quality system breakdowns.Apply advanced root cause analysis methodologies, including 5 Whys, Fishbone/Ishikawa, fault tree analysis, process mapping, statistical analysis, and risk-based problem solving to identify true systemic causes.Develop and review corrective and preventive action plans that address immediate containment, correction, root cause, systemic risk, implementation controls, and long-term prevention.Define and assess CAPA effectiveness criteria, including objective evidence, measurable outcomes, sustainability checks, and linkage to risk management, complaints, nonconformances, audits, and process performance data.Through the site’s CAPA Review Board drives accountability for the CAPA progress, including monitor CAPA timeliness, quality of investigation documentation and root cause determination, action completion, verification activities, recurrence trends, and closure readiness within the electronic Quality Management System. As well as escalation of overdue, high-risk or poor quality CAPAs to leadership through governance mechanisms.Analyze CAPA metrics, quality data, and recurring issue trends to identify systemic quality risks, recommend escalation when appropriate, and provide meaningful inputs to Management Review and Quality leadership.Provide expert guidance, coaching, and training to CAPA owners, investigators, Quality Engineers, Operations, Manufacturing Engineering, Regulatory Affairs, and other cross-functional partners on CAPA expectations and best practices.Represent CAPA records, investigation rationale, effectiveness evidence, and quality system linkages during internal audits, customer audits, Notified Body assessments, and regulatory inspections.Partner with site and corporate Quality leadership to improve CAPA procedures, governance, review boards, escalation practices, electronic system use, and harmonization across business units or manufacturing sites.Lead or support CAPA remediation activities, including legacy record review, gap assessment, documentation correction, action plan enhancement, and closure strategy for high-priority or compliance-sensitive records.Drive continuous improvement initiatives using Lean, Six Sigma, statistical techniques, and quality engineering tools to improve CAPA effectiveness, prevent recurrence, and reduce quality system risk.Responsible for following all company guidelines related to Health, Safety, and Environmental practices and ensuring that resources needed to do so are available and in good condition.
Leadership: Provides senior technical leadership, coaching, and work direction to CAPA owners, investigators, Quality Engineers, and cross-functional teams. Influences without direct authority by setting expectations, reviewing work quality, challenging investigation logic, and ensuring commitments are completed effectively and on time.
General Direction: Receives broad objectives and strategic priorities from management. Works independently to define approach, lead complex assignments, make risk-based recommendations, and escalate significant quality or compliance concerns when appropriate.

EDUCATION and/or EXPERIENCE:Bachelor’s degree in Engineering, Biomedical Engineering, Science, or a related technical discipline required; advanced degree preferred.ASQ Certified Quality Engineer, Certified Quality Auditor, Six Sigma, or equivalent certification preferred.Experience supporting or representing CAPA, investigation records, audit responses, and effectiveness evidence during FDA, Notified Body, customer, internal, or corporate quality system audits is strongly preferred.Ability to effectively present CAPA performance, systemic issue analysis, risk-based recommendations, remediation status, and quality system improvement plans to top management and cross-functional governance forums.Ability to define complex problems, collect and analyze data, establish facts, evaluate risk, draw valid conclusions, and confirm effectiveness using appropriate statistical techniques and tools such as Minitab, Excel, or equivalent software.Bilingual Spanish and English. Demonstrated proficiency in spoken and written in both languages, at a minimum B2 level, with the ability to effectively facilitate meetings, lead cross-functional discussions, prepare clear and audit-ready documentation, deliver training, and communicate complex quality and regulatory concepts to global stakeholders, senior leadership, customers, auditors, and regulatory authorities.Proficiency with Microsoft Office applications and electronic Quality Management System platforms used for CAPA, nonconformance, complaint, audit, document control, training, and quality data management.
OTHER SKILLS and ABILITIES:Excellent written and verbal communication skills, including the ability to write clear, complete, audit-ready CAPA investigations, rationales, action plans, and effectiveness assessments.Demonstrated ability to communicate complex quality issues, investigation conclusions, regulatory expectations, and risk-based recommendations to senior leadership, customers, regulatory agencies, and cross-functional stakeholders.Expert ability to interpret and apply quality system procedures, medical device regulations, international standards, technical data, risk documentation, trend reports, and statistical outputs.Recognized subject matter expertise in CAPA, nonconformance management, complaint escalation, audit response, risk management, process validation, manufacturing quality, and quality system improvement within the medical device industry.Extensive experience leading CAPA investigations and remediation activities in a regulated medical device environment, including use of structured root cause analysis, containment, correction, corrective action, preventive action, effectiveness verification, and recurrence prevention.Advanced knowledge of CAPA process design, CAPA governance, CAPA Review Boards, electronic Quality Management Systems, quality metrics, management review inputs, continuous improvement, Lean, and Six Sigma concepts.Strong working knowledge of applicable medical device quality system requirements, including ISO 13485, FDA QMSR requirements, risk management expectations, and related global regulatory expectations for corrective and preventive action.Typically requires 10 or more years of progressively responsible Quality Engineering, Quality Systems, CAPA, or related medical device experience, including demonstrated experience leading complex CAPAs and influencing cross-functional teams.Proven ability to identify, prioritize, and implement improvements to CAPA processes, investigation quality, documentation practices, timeliness, effectiveness, and overall Quality Management System performance.
MANUAL DEXTERITY: Manual dexterity sufficient to reach/handle items and work with the fingers.VISION REQUIREMENTS: No special vision requirementsWORK SCHEDULE/HOURS: Monday – Friday 8:00 am - 5:00 pm.TRAVEL: MinimalENVIRONMENTAL WORKING CONDITIONS: Well-lighted, heated and/or air-conditioned indoor office setting with adequate ventilation.PHYSICAL DEMANDS: Other physical working conditions: Moderate noisePHYSICAL ACTIVITY LEVEL: Sedentary physical activity performing non-strenuous daily activities of an administrative nature.Number of buildings that works: Four
COMMENTS: This position description is an outline of the major recurring responsibilities of the job. It is not intended to be all-inclusive of the work to be performed. The incumbent(s) will typically perform other related job objectives, special assignments and less significant responsibilities.