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Quality Engineer (Med Device)

Actalent

Posted Thursday, August 21, 2025

Posting ID: JP-005493174

Carlsbad, CA
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Job Title: Quality Engineer


Job Description

We are seeking a skilled Quality Engineer to join our team and contribute engineering solutions in Design Assurance, Design Controls, Risk Management, and Statistical Techniques. This role is integral to our new product development, ensuring compliance and driving improvements in world-class manufacturing.


Responsibilities

  • Provide engineering solutions in Design Assurance, Design Controls, Risk Management, and Statistical Techniques.
  • Lead design assurance and development activities, including engineering studies, feasibility testing, and drawing reviews for new product development.
  • Create and maintain risk management files per ISO and regulations, including plans and hazard analyses.
  • Develop quality assurance specifications, test methods, inspection procedures, and sampling plans.
  • Lead test method development and validation.
  • Support new product launch, validation, and design transfer into manufacturing.
  • Address production issues and drive improvements for compliance and world-class manufacturing.
  • Implement and review changes to products, SOPs, and other documentation for regulatory submissions.
  • Support supplier evaluation and qualification.

Essential Skills

  • Proficiency in Design Assurance, Design Controls, and Test Method Development.
  • Experience working with catheters in a startup environment.
  • Hands-on experience in a regulated industry.
  • Experience supporting audits, equipment and calibration, updating work instructions and SOPs, change orders, IQ, TFIQ, and release of equipment.
  • Knowledge of Software Development Life Cycle Processes (IEC) and Usability Engineering Processes (IEC).

Additional Skills & Qualifications

  • Bachelor’s degree in engineering or related field with 4 years of relevant experience, or Master’s degree with 2 years of experience.
  • Experience working with suppliers.
  • Must be open to working in a clean room environment.

Work Environment

This is an onsite position within a collaborative environment that includes roles such as Sr Quality Manager, Software Engineer, Doc Control, Quality Intern, and QC. Our work environment offers impactful work in the medical device industry, career development, and comprehensive benefits including medical, dental, vision, 401(k), PTO, and disability support.

Compensation:$125000

Contact Information

Email: hfenwick@actalentservices.com

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
On-Site
Auditing
Change Orders
New Product Development
Risk Management
Software Engineering
Software Development Life Cycle
Quality Assurance
Medical Devices
Quality Management
Usability
Design Assurance
Cleanrooms
Sampling (Statistics)
Calibration
Test Method
Supplier Evaluation

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