Quality Design Engineer

Orcapod Consulting Services; Pune District, Gurugram District; Hybrid; INR 1,800,000 - 2,400,000; Full time

Job summary

Orcapod Consulting Services is seeking a Design Quality Engineer (Medical Domain) for Pune/Gurgaon with 6–8 years of experience in medical device quality engineering. The role requires strong knowledge of ISO 13485, FDA QSR, EU MDR, and ISO 14971 risk management.

Responsibilities include Design Control, Process Validation, CAPA, and Supplier Quality, with proficiency in Minitab/JMP/Excel for statistical analysis and problem solving.

Qualifications

• Bachelor's degree in engineering, quality, or related field; master's degree preferred.
• 5+ years of medical device quality engineering experience.
• Strong knowledge of ISO 13485, FDA QSR (21 CFR Part 820), EU MDR, and ISO 14971 risk management.

Responsibilities

• Experience with Design Control, Process Validation, CAPA, and Supplier Quality.
• Proficiency in statistical analysis tools and problem-solving methodologies (8D, DMAIC).

Skills

Quality engineering

CQE certification

Risk management ISO 14971

Design Control

CAPA

Statistical analysis (Minitab/JMP)

Excel

Education

Bachelor's degree in Engineering/Quality/related field

Master's degree preferred

Tools

Minitab

JMP

Excel

Job description

Design Quality Engineer (Medical Domain)

Hi,

We are hiring for

Location :- Pune/Gurgaon

Experience :- 6-8 years

• Bachelors degree in Engineering, Quality, or a related field (Masters preferred).
• 5+ years of experience in medical device quality engineering or a related field.
• Strong knowledge of ISO 13485, FDA QSR (21 CFR Part 820), EU MDR, and risk management (ISO 14971).
• Experience with Design Control, Process Validation, CAPA, and Supplier Quality.
• Proficiency in statistical analysis tools (Minitab, JMP, Excel) and problem-solving methodologies (8D, DMAIC).
• Certified Quality Engineer (CQE) or Six Sigma certification is a plus.
• Building Strategic Working Relationships-Developing and using collaborative relationships to facilitate the accomplishment of work goals.
• Quality Orientation-Accomplishing tasks by considering all areas involved, no matter how small; showing concern for all aspects of the job; accurately checking processes and tasks; being watchful over a period of time.
• Decision Making- Identifying and understanding issues, problems, and opportunities; comparing data from different sources to draw conclusions; using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints, and probable consequences.
• Performance/Work Standards-Setting high standards of performance for self and others; assuming responsibility and accountability for successfully completing assignments or tasks. (Flawless Execution of the Basics).

Information Monitoring- Setting up ongoing procedures to collect and review information needed to manage an organization or ongoing activities within it.

Thanks and Regards

Shakila | Senior Consultant - People Success
[phone] | [e-mail]