Quality Systems Engineer – CAPA & Validation

Job Details

• Location: Warsaw, IL

• Duration: 6 months

• GBaMS ReqID: 11001464

• Experience Required: 4–6 years

• Education: Minimum B.S. degree from an ABET-accredited school or global equivalent

• Preferred Industry: Medical devices, particularly Orthopedic

Technical / Functional Skills

• Strong knowledge ofMedical Device Quality Management Systems (QMS) and regulatory requirements.

• Knowledge of:

  • FDA 21 CFR Part 820

  • ISO 13485

  • Risk Management

  • CAPA

  • Change Control

  • Document Control

  • Validation Processes

• Experience withCAPA investigations, remediation, implementation, and Verification of Effectiveness (VoE).

• Hands-on experience with:

  • Spreadsheet Validation

  • Computer System Validation (CSV)

  • Software Validation

  • Validation Lifecycle Documentation

• Ability to perform:

  • Risk Assessments

  • Impact Assessments

  • Gap Analyses

  • Root Cause Investigations

• Experience using quality tools such as:

  • Fishbone

  • 5-Why

  • FMEA

  • Risk-Based Decision Making

• Experience creating and reviewing:

  • Validation Plans

  • Validation Reports

  • Traceability Matrices

  • Risk Assessment Reports

  • Quality Records

• Strong understanding ofChange Management and Document Control processes.

• Experience with controlled document updates, routing, approvals, and implementation.

• Experience supporting QMS compliance with internal procedures and global standards for spreadsheet and software validation.

• AdvancedMicrosoft Excel skills, including:

  • Formula review

  • Data analysis

  • Spreadsheet controls

  • Cell protection

  • Audit trail documentation

• Experience with electronic QMS platforms such asGreenlight Guru or equivalent document management systems.

• Ability to analyze quality data and prepare:

  • Status dashboards

  • Action trackers

  • Management reports

• Strong stakeholder management, communication, and project coordination skills.

• Ability to work in cross-functional and global environments.

• Knowledge of:

  • Manufacturing

  • Quality Assurance

  • Supplier Quality

  • Process Validation

  • Regulatory Compliance

  • Medical Device Industry

Roles & Responsibilities

• Review spreadsheet inventories and assess validation requirements according to applicable procedures and quality standards.

• Develop and maintain spreadsheet validation documentation, including:

  • Validation Plans

  • Validation Reports

  • Risk Assessments

  • Validation Traceability

  • Impact Assessments

• Verify:

  • Spreadsheet controls

  • Formula integrity

  • Access restrictions

  • Document control requirements

  • Compliance with approved validation procedures

• Support closure ofCAPA corrective actions related to spreadsheet remediation and validation.

• Assist with aligning local procedures with global requirements.

• Support updates to:

  • Software validation processes

  • Spreadsheet validation processes

  • Change control procedures

• Prepare, review, and update controlled:

  • Quality Documents

  • SOPs

  • Forms

  • Templates

  • Work Instructions

  • Supporting Records

• Conduct gap assessments and impact analyses.

• Identify compliance issues and recommend corrective actions.

• Coordinate with:

  • Quality

  • Engineering

  • Manufacturing

  • Regulatory Affairs

  • Document Control

• Obtain required reviews and approvals and ensure timely closure of action items.

• Track:

  • Project milestones

  • Deliverables

  • Risks

  • Issues

  • Dependencies

• Provide regular project status updates to leadership.

• Support preparation ofCAPA implementation evidence.

• Maintain audit-ready documentation packages.

• Assist in developingVerification of Effectiveness (VoE) plans.

• Support:

  • Sampling strategies

  • Record reviews

  • Effectiveness evidence packages

  • Long-term CAPA closure requirements

• Participate in:

  • Internal audits

  • Compliance assessments

  • Management reviews

  • Remediation activities

• Support continuous improvement initiatives focused on:

  • Quality System Processes

  • Validation Compliance

  • Regulatory Readiness

• Ensure all deliverables meet applicableClient Biomet procedures, quality requirements, and project timelines.

Education Requirements

• Minimum: B.S. degree from an ABET-accredited school or global equivalent.

• Acceptable engineering disciplines include:

  • Mechanical Engineering

  • Mechanical Engineering Technology

  • Biomedical Engineering

  • Bioengineering

  • Biomedical Engineering Technology

  • Bioengineering Technology

  • Aerospace Engineering

  • Aeronautical Engineering

• Experience: 2–4 years specified under the education requirement.

• Medical device experience preferred, especiallyOrthopedic industry experience.