Quality Engineer IV – Lead Workcell Quality Operations

About the role

We are seeking a Quality Engineer IV to lead the Workcell Quality Operations and New Product Introduction (NPI) team. The role is responsible for implementing quality plans, overseeing inspections, and ensuring compliance with company, customer, and regulatory requirements.

Key responsibilities

• Lead the Workcell Quality Operations or NPI team, including Quality Engineers, technicians, and inspectors.
• Develop, modify, and maintain quality evaluation and control plans and protocols for processing materials into partially finished or finished products.
• Own the development and implementation of inspection, testing, and evaluation methods for products and production equipment.
• Support quoting activities by participating in initial process design, development, and implementation phases.
• Lead quality operation activities to assure correct execution of quality tests for product release.
• Approve batch record documentation and revise manufacturing processes.
• Serve as Validation Owner, responsible for development, approval, and execution of validation activities.
• Support plant Quality System software validation and ensure compliance with ISO 13485, CFR 21 Part 820, and local procedures.
• Design and analyze inspection and testing processes, conduct quality assurance tests, and perform statistical analysis.
• Manage statistical analysis requirements and control limits for SPC.
• Audit quality systems, identify deficiencies, and drive corrective actions (CAPA) in line with ISO 9001, ISO 13485, and Jabil Problem Solving methods.
• Own CAPAs and lead implementation as needed.

Required profile

• Proven experience leading quality engineering teams in a manufacturing environment.
• Strong knowledge of ISO 13485, ISO 9001, and CFR 21 Part 820 requirements.
• Experience with validation planning, execution, and documentation.
• Ability to conduct root‑cause investigations and develop corrective actions.
• Familiarity with statistical analysis and SPC methodologies.
• Experience with CAPA management and quality system audits.

Required skills

• Statistical Process Control (SPC)
• Lean manufacturing concepts
• Data analysis for quality metrics
• Validation procedures (ISO 13485)
• CAPA management
• Quality system auditing
• Knowledge of CFR 21 Part 820
• ISO 9001 compliance
• Inspection and testing protocol development