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

• Track Wise

• Share Point

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