Quality Engineer- Medical Device

HealthCare Recruiters International; Los Gatos (CA); On-site; USD 70,000 - 230,000; Full time

Job summary

Join a dynamic startup innovator in the cardiac repair space as a Quality Engineer. In this role, you will develop and maintain quality standards for new product development. You will oversee product quality in a cleanroom environment, ensuring compliance with FDA regulations and ISO standards. Collaborate with cross-functional teams to meet biocompatibility requirements and lead validation activities. This is an exciting opportunity to make a significant impact in the medical device industry while working in a supportive and innovative environment.

Benefits

Medical insurance

Vision insurance

Qualifications

• 6+ years of medical device R&D and quality manufacturing experience.
• In-depth knowledge of FDA regulations and ISO standards.

Responsibilities

• Oversee product quality during all stages of development.
• Ensure compliance with GMP regulations and quality systems.
• Collaborate with R&D and Regulatory Affairs teams.

Skills

FDA regulations

ISO 13485

Quality Assurance

Good Manufacturing Practices (GMP)

Nonconforming material investigations

CAPAs implementation

Sterilization processes

Six Sigma

Education

BS in Engineering

MS in Engineering

Job description

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Our client is an exciting, well-funded startup innovator in the cardiac repair space. The Quality Engineer/Sr Quality Engineer will be responsible for developing, applying, revising, and maintaining quality standards for the new product development process.

We are partcularly interested in QEs with prior catheter and/or structural heart and/or surgical robotics product development experience!

Responsibilities

• Oversee product quality during all stages of product development and production in a cleanroom manufacturing environment
• Ensure compliance with Good Manufacturing Practices (GMP) regulations and internal quality management systems throughout the manufacturing process
• Collaborate with R&D and Regulatory Affairs teams to ensure that biocompatibility requirements are met for medical devices
• Provide guidance on sterilization processes and validations to ensure product safety and compliance
• Facilitate sterilization activities including batch release, sterilization validation, and coordination with third party sterilizers
• Lead and support process validation activities, including IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification), for new and existing manufacturing processes

Qualifications/Experience

• BS/MS in a relevant engineering discipline
• 6+ yrs of relevant medical device R&D and quality manufacturing experience
• In-depth knowledge of FDA regulations, ISO 13485, and other relevant quality standards for medical devices
• Experience with nonconforming material investigations and implementing effective CAPAs
• Certifications such as Six Sigma and ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) are desirable

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Engineering, Manufacturing, and Quality Assurance

• Industries

  Medical Equipment Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

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