Design Quality Engineer

External Skills And Expertise:
Job Description & Skill Requirement:

Skills: Design Control, Risk Assessment, FMEA, V&V, DHF Remediation ,Test method validation & Test method verification

Job Description
Design Quality Engineer / DHF Remediation Specialist - OHC Products (2 offshore and 2 onsite)

Key Responsibilities
Requirements Management & Design Controls
• Review, update, and remediate product requirements documentation.
• Identify requirements gaps, inconsistencies, and missing design inputs.
• Support creation and maintenance of Requirements Traceability Matrix (RTM).
• Ensure bi-directional traceability between:
o User Needs
o Design Inputs
o Design Outputs
o Risk Controls
o Verification Evidence
• Ensure compliance with client Design Control procedures and applicable quality requirements
Verification & Validation Support
• Review existing verification protocols, reports, and test evidence.
• Assess requirement coverage and identify verification gaps.
• Update verification documentation and traceability records.
• Support verification remediation activities aligned with design requirements.
• Collaborate with onsite teams performing test method development and execution.
Risk Management & FMEA Remediation
• Review and update Risk Management Files.
• Align DFMEA/PFMEA documentation with design requirements and verification activities.
• Ensure risk controls are adequately traced to verification evidence.
• Participate in risk assessments, residual risk evaluations, and remediation activities.
• Support compliance with ISO 14971 risk management processes.
DHF / Documentation Remediation
• Perform gap assessment of existing DHF documentation.
• Create, revise, and remediate:
o Requirements Specifications
o Verification Plans and Reports
o Risk Management Documents
o Traceability Matrices
o Design Review Documentation
o Design Change Records
• Support development of a complete and audit-ready product baseline.
• Maintain document quality, consistency, and configuration control.
Regulatory & Quality Compliance
• Support compliance activities against:
o FDA 21 CFR Part 820 / QMSR
o ISO 13485
o ISO 14971
o Applicable client Quality Management Systems
• Participate in internal reviews and audit readiness activities.
• Ensure documentation supports a defensible regulatory position.

Experience:

• 5-10+ years of medical device industry experience.
• Minimum 3 years in Design Quality, Systems Engineering, or DHF remediation projects.
• Experience supporting remediation programs, design control activities, or technical file updates.
• Experience working with global cross-functional teams

Mandatory Skills
Technical Competencies
• Requirements Management
• Design Controls
• Design History File (DHF)
• Risk Management (ISO 14971)
• FMEA (DFMEA/PFMEA)
• Verification & Validation
• Requirements Traceability
• Gap Assessment
• Root Cause Analysis
• Change Management
Quality & Regulatory Knowledge
• FDA 21 CFR 820/QMSR
• ISO 13485
• ISO 14971
• Medical Device Product Development Lifecycle
Documentation Skills
• Technical writing
• Design Documentation Remediation
• Review and approval workflows
• Audit-ready document preparation
Tools (Preferred)
• Windchill / Teamcenter / Agile PLM
• TrackWise
• SharePoint
Preferred Experience (Highly Desirable)
• Oral Health Care (OHC) products.
• Consumer healthcare devices.
• Whitening systems, oral care devices, or regulated consumer products.
• Technical file or DHF remediation projects.
• Large-scale remediation programs involving multiple products.
• End-to-end traceability remediation initiatives.




Qualification:
Required Qualifications
Education
• Bachelor's or Master's degree in:
o Biomedical Engineering
o Mechanical Engineering
o Electronics Engineering
o Medical Devices
o Related Engineering Discipline