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Quality Engineer- Medical Device

International Permanent USD80,000 - USD90,000 per year View Job Description
Quality Engineer:This Quality Engineer role focuses on ensuring product and process compliance with medical device regulations by conducting risk assessments, supporting audits, and driving continuous improvement initiatives. The position involves cross-functional collaboration, quality documentation, and active participation in new product development to maintain safety, efficacy, and regulatory standards.
  • Cross collaboration Opporunities
  • Flexibility

About Our Client

Who they are:

This company specializes in developing and manufacturing medical devices with a strong emphasis on quality, safety, and regulatory compliance. It fosters a culture committed to continuous improvement and ethical practices, aiming to deliver reliable, high-performance products to the healthcare industry

Job Description

The Key Duties as a Quality Engineer:



  • Conduct compliance assessments, root cause analyses, and implement corrective and preventive actions (CAPA).


  • Develop, revise, and maintain quality procedures, inspection protocols, and risk management files.


  • Perform statistical analysis and trend reporting to support process improvements and reduce defects or complaints.


  • Facilitate risk assessments (e.g., FMEA) and support quality oversight for new product development and introduction.


  • Evaluate supplier and internal changes, manage product quality reviews, and support field action activities.


  • Ensure adherence to industry standards and regulations (e.g., ISO 13485, FDA 21 CFR Part 820, EU MDR)

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

What you will bring:



  • Holds a Bachelor's degree in an engineering discipline from an accredited institution.


  • Has a minimum of 4 years of experience in the medical device industry or a similarly regulated field.


  • Demonstrates strong knowledge of quality and regulatory standards, including ISO 13485, ISO 14971, and FDA 21 CFR Part 820.


  • Possesses excellent communication skills, attention to detail, and a proactive, adaptable mindset.


  • Capable of working independently or collaboratively, with proven ability to manage complex quality projects and initiatives.



What's on Offer

What is on offer for you:



  • Opportunity to work in a quality-driven, collaborative environment focused on innovation in medical device manufacturing.


  • Involvement in impactful projects that support patient safety, product excellence, and regulatory compliance.


  • Professional growth through diverse responsibilities in quality systems, risk management, and new product development.


  • Competitive compensation package with comprehensive benefits, including health insurance and other employee perks.
Contact
Bridget Petti
Quote job ref
JN-062025-6773276

Job summary

Sector
Engineering & Manufacturing
Sub Sector
Quality, Technical
Industry
Industrial / Manufacturing
Location
International
Contract Type
Permanent
Consultant name
Bridget Petti
Job Reference
JN-062025-6773276
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