Design Quality Engineer

Indegene; Hyderabad, Pune District, Bengaluru; Hybrid; INR 1,200,000 - 1,800,000; Full time

Job summary

Indegene is seeking a Quality Assurance professional to own the product lifecycle quality plans and oversee design validation, risk management, and post-market analysis. The role requires strong regulatory knowledge in medical devices and the ability to drive QMS processes across development teams.

The candidate will validate design inputs, ensure compliance in design reviews and transfers, and implement robust quality practices such as FMEA and RCA.

Qualifications

• Bachelor's Engineering degree with 5-7 years of related experience or Master’s with 3+ years of related experience - Mechanical/ Electrical/ Electronic or Equivalent Engineering
• Engineering Degree or equivalent experience in the medical device industry
• 3+ years’ experience with a medical device company preferably

Responsibilities

• Ensures that appropriate quality plans are made that include all stages of the life cycle of the product and support Quality Plan design.
• Provides effective oversight of the execution of the Quality Plan, any Risk Management activities, and all design-related activities during the product/system lifecycle.
• Validates key design inputs like usability, reliability, Performance, supportability, manufacturability, localizability, security, Privacy, serviceability, sustainability, and costs.
• Performs assessment of product quality performance and post-market product quality analysis.
• Uses post-market analytics and statistics to report on product quality performance in the field and initiates field actions when enquired.
• Ensure compliance requirements are met during design reviews, design Verification, validation, and design transfer.
• Apply and Facilitate design for quality and reliability best practices (FMEA, robust design, V&V, RCA, Problem-solving).

Skills

Quality assurance

Regulatory awareness

Risk management

V&V

RCA

Requirements management

Education

Bachelor's Engineering (Mech/Elec/Elect/Equivalent)

Master's degree in related field

Tools

FMEA

V&V tools

Audit tools

Job description

Role & responsibilities

• Ensures that appropriate quality plans are made that include all stages of the life cycle of the product and support Quality Plan design.
• Provides effective oversight of the execution of the Quality Plan, any Risk Management activities, and all design-related activities during the product/system lifecycle.
• Validates key design inputs like usability, reliability, Performance, supportability, manufacturability, localizability, security, Privacy, serviceability, sustainability, and costs.
• Performs assessment of product quality performance and post-market product quality analysis.
• Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers, or design teams) and initiates field actions when enquired.
• Ensure compliance requirements are met during design reviews, design Verification, validation, and design transfer.
• Apply and Facilitate design for quality and reliability best practices (FMEA, robust design, V&V, RCA, Problem-solving).

Preferred candidate profile

• Applied knowledge of appropriate global medical device or consumer product regulations, requirements, and standards (21 CFR Parts 820, ISO13485, ISO14971, MEDDEV, EU MDR, etc.).
• Experience or understanding of Software or Hardware development, Verification and Validation, Risk management, RCA, Requirements Management, Design, and Usability.
• Understand Sample Size Determination and Statistical Methods, Safety Risk Management (i.e ISO 14971), and Failure Modes and Effects Analysis (FMEA) / Fault Tree Analysis.
• Understand a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements.
• Understand the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up.
• Be able to develop and implement quality programs, including tracking, analyzing, reporting, and problem solving.

Must have:

• Bachelors Engineering degree with 5-7 years of related experience or Master’s degree with 3+ years of related experience -Mechanical/ Electrical/ Electronic or Equivalent Engineering
• Engineering Degree or equivalent experience in the medical device industry
• 3+ years’ experience with a medical device company preferably