Quality Engineer -Post Market Surveillance (Medical Devices)

Position: Quality Engineer, Post Market Surveillance (Contractor Role)

Job Title: Quality Engineer

Quality Engineer, PMS - Individual Contributor

Reports to: Associate Manager, PMQ Trauma & Extremities

Budget: 7-8 LPA

Location: Gurugram

Notice: Immediate -30 Days

Experience: 2-4 Years

Roles and Responsibilities

The Quality Engineer will work on all the various aspects of Post Market Surveillance and enters customer complaints into the company-wide complaint handling system and follows methods to analyze the complaints, for the Trauma & Extremities business. He/She should be competent to compile the Product Safety Usage Reports (PSURs) independently. These activities as they relate to Post Market Surveillance and EU MDR requirements include but are not limited to identifying strategic focus areas for continuous improvements, product/process enhancements, implementing proactive quality activities, monitoring, and measuring the overall performance, and ensuring compliance to quality systems and regulatory requirements.

Key Responsibilities include:

• Create PMS plan, PMS report, PSUR report as per EUMDR, Trend report & Complaint analysis Risk management –Risk assessment.
• Propose strategies and solutions to data issues or challenges that occur during the PSUR writing and conclusion process.

Skill Set:

• Proficient in post market surveillance regulations, specifically EU MDR.
• Hands on experience of Risk Management process as per ISO 14971
• Sound knowledge on complaint trending
• Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies.
• Demonstrated ability to self-motivate, ability to prioritize tasks in a deadline-driven environment.
• Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams.
• Applied understanding of GDP, ISO 9001 & ISO 13485, FDA 21CFR Part 822 / 820

Additional:

• Effective interpersonal communications & Excellent analytical skills.
• Demonstrated organizational and written/verbal communication skills.
• Drive self-initiative to improve process
• Ability to work independently and in a team environment

Desired Profile

Education B. Tech / B.E in a field related to the life sciences or a relevant medical engineering field (biology, physiology, biomaterials, biomedical engineering or similar).

Experience: 2 to 4 years of experience in Scientific or Medical Writing, and/or Quality and regulatory experience in post market surveillance.

• Experience with medical device, orthopedic or trauma devices preferred

Personality:

Proactive, independent, team player with a strong service mentality.

You are characterized by analytical and transdisciplinary reasoning, with a good attention to detail.

You value an international working environment, working across sites and indications.

Job Type: Full-time

Pay: ₹56,000.00 - ₹67,000.00 per month

Work Location: In person