Drive departmental goals, KPIs and performance expectations aligned with site quality strategy.
Identify training needs and ensure compliance with quality and regulatory training requirements.
Foster a culture of behavior based quality, accountability, continuous improvement and customer focus.
Lead the quality organization during customer escalations, quality crises, product containment and recovery activities.
Promote collaboration across Manufacturing, Engineering, Supply Chain, Regulatory Affairs, and Operations teams.
Quality Management System (QMS)
Ensure effective implementation, maintenance and continuous improvement of the Quality Management System in compliance with:
ISO 13485
FDA 21 CFR Part 820 / QMSR
MDSAP
Customer-specific requirements
Monitor QMS metrics and drive system improvements.
Review and approve quality procedures, work instructions, specifications, forms and records.
Support Management Review and Quality Review Board activities.
Quality & Technical Management
Lead Quality Engineering support for manufacturing operations and NPI projects.
Develop and maintain Quality Plans, Control Plans and APQP deliverables.
Drive process validation and qualification activities including IQ, OQ and PQ.
Lead Process FMEA, Risk Assessment and Control Plan development.
Support quotation and transfer activities through quality planning and risk evaluation.
Establish inspection methodologies, acceptance criteria, sampling plans and measurement systems.
Review and improve inspection processes, gauges, fixtures and quality controls.
Analyze quality performance data and identify opportunities for process improvement.
Lead implementation of SPC, process capability studies and quality monitoring systems.
Partner with Engineering and Operations to improve yield, reduce defects and lower Cost of Poor Quality (COPQ).
CAPA, Nonconformance & Complaint Management
Lead investigations related to
Nonconforming product
Customer complaints
Audit findings
Process deviations
Supplier quality issues
Utilize structured problem-solving methodologies including
8D
5 Why
Fishbone Analysis
Ensure timely implementation and closure of corrective and preventive actions (CAPA).
Verify effectiveness of CAPA actions and drive sustainable solutions.
Monitor recurring quality trends and drive systemic improvements.
Customer Quality Management
Serve as quality interface for healthcare and medical device customers.
Lead responses to customer quality issues, complaints, audits and corrective action requests.
Facilitate customer visits, quality reviews and business review meetings.
Support customer qualification, product transfers and new product launches.
Drive customer satisfaction through proactive quality management and continuous improvement activities.
Supplier Quality Management
Support supplier qualification, monitoring and development activities.
Review supplier quality performance metrics and drive improvement actions.
Lead Supplier Corrective Action Requests (SCAR) and supplier investigations.
Participate in supplier audits and supplier process improvement initiatives.
Partner with Supply Chain and Procurement teams to ensure supplier compliance.
Validation & Risk Management
Ensure compliance with validation requirements for
Equipment Qualification (IQ/OQ/PQ)
Process Validation
Software Validation
Packaging Validation
Test Method Validation
Lead risk management activities in accordance with ISO 14971.
Participate in Design Reviews, Process Reviews and Change Control evaluations.
Assess quality and regulatory risks associated with product and process changes.
Audit & Regulatory Compliance
Lead and support
Internal Audits
Customer Audits
Supplier Audits
Regulatory Inspections
Certification Audits
Ensure audit findings are addressed and closed within required timelines.
Maintain a state of inspection readiness.
Support implementation of regulatory and customer requirement changes.
Ensure compliance with company policies, quality requirements, regulatory standards and industry best practices.
Business Strategy & Continuous Improvement
Execute departmental quality strategies aligned with business goals.
Drive Lean Manufacturing, Six Sigma and Operational Excellence initiatives.
Establish quality improvement roadmaps to improve
Customer satisfaction
Product quality
Operational efficiency
Regulatory compliance
Monitor departmental performance and communicate results to management.
Support annual operating plan and cost reduction initiatives.
PREFERRED REQUIREMENTS
Education
Bachelor's Degree in Engineering, Biomedical Engineering, Manufacturing Engineering, Quality Management or related discipline.
Experience
Minimum 7-10 years of Quality Engineering or Quality Assurance experience in medical devices, healthcare, life science or regulated manufacturing environments preferred,
Experience in Surface Mount Technology (SMT), Printed Circuit Board Assembly (PCBA), and High-Level Assembly (HLA) manufacturing environments is preferred.
Candidates should have practical exposure to process controls, inspection and testing requirements, defect analysis, corrective actions, and quality performance monitoring across these assembly operations.
Experience supporting medical device, healthcare, or other regulated customers—including customer audits, product transfers, qualification activities, complaint investigations, and compliance with applicable quality and regulatory requirements—would be an added advantage.
Minimum 3-5 years of leadership or supervisory experience.
Preferred Qualifications
Lead / Auditor Certification (ISO 13485)
ASQ Certified Quality Engineer (CQE) / Certified Quality Auditor (CQA) – optional
Key Knowledge & Skills
ISO 13485
FDA QSR / QMSR
MDSAP
ISO 14971 Risk Management
APQP, PFMEA, Control Plan
CAPA and Root Cause Analysis
SPC and Statistical Analysis
Process Validation (IQ/OQ/PQ)
Supplier Quality Management
Customer Quality Management
Lean Manufacturing and Six Sigma
Strong leadership and stakeholder management skills
Key Performance Indicators (KPIs)
Customer Complaint Rate
CAPA On-Time Closure %
Audit Finding Closure Effectiveness
First Pass Yield (FPY)
Cost of Poor Quality (COPQ)
Supplier PPM
Internal Defect Rate
Customer Escapes
Regulatory Compliance Status
Employee Development & Engagement
BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver’s license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact your local police department. Any scam job listings should be reported to whatever website it was posted in.
Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, genetic information, veteran status, or any other characteristic protected by law.
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