Principal Quality Engineer

Jobot; Irvine (CA); On-site; USD 89,544 - 117,096; Full time

Benefits offered by this job

Company Equity!

Excellent medical, dental, & vision package!

401(k) with a match!

Generous PTO!

Opportunity to make a difference!

Job summary

A leading medical device company is seeking an experienced Principal Quality Engineer to lead quality initiatives ensuring compliance with FDA regulations. The ideal candidate will have over 12 years of experience in quality engineering and in-depth knowledge of ISO 13485 and CAPA management. This is a contract-to-hire position that not only offers competitive compensation but also an opportunity to significantly impact patient care and quality of life. Benefits include company equity and comprehensive medical packages.

Qualifications

• 12+ years of experience in a quality engineering role.
• Extensive knowledge of quality systems in the medical device industry.
• Certifications such as CQE or CQA are preferred.

Responsibilities

• Lead quality systems compliance with FDA and ISO 13485.
• Analyze and manage CAPA for quality issues.
• Conduct audits to maintain regulatory compliance.
• Collaborate with teams for continuous improvement.
• Provide consultation on quality systems and risk management.

Skills

Strong background in quality engineering

Knowledge of FDA regulations

ISO 13485 expertise

CAPA management

Problem-solving methodologies

Education

Bachelor's degree in Engineering, Quality Assurance, or related field

Job description

Overview

Medical Device Leader! Principal Quality Engineer Opportunity! This Jobot Consulting job is hosted by: David DeCristofaro. Are you a fit? Easy Apply now by clicking the "Easy Apply" button and sending us your resume. Salary: $65 - $85 per hour.

About Us

We are a leading medical device company that operates privately and is committed to enhancing the care and quality of life of patients with kidney disease. Our goal is to create cutting-edge solutions that enable patients and their healthcare providers to manage kidney disease with ease.

Why Join Us?

• Company Equity!
• Excellent medical, dental, & vision package!
• 401(k) with a match!
• Generous PTO!
• Opportunity to make a difference in people\'s lives!

Job Details

Contract-to-Hire position. This role is a dynamic and experienced Principal Quality Engineer to join our team. The role will lead quality engineering initiatives ensuring ongoing safety, efficacy, and compliance of medical devices as they enter the market. The ideal candidate will have a strong background in quality engineering within the Medical Device industry, with a focus on FDA regulations, ISO 13485, CAPA, and other regulatory and compliance requirements.

Responsibilities

1. Lead the development and implementation of quality systems in compliance with FDA and ISO 13485 regulations.
2. Analyze and manage Corrective and Preventive Actions (CAPA) to ensure effective resolution of quality issues.
3. Utilize problem-solving methodologies such as Fishbone or DMAIC to identify root causes and implement corrective actions.
4. Maintain the FDA Quality Management System Reporting (QMSR) and ensure that all quality metrics are met or exceeded.
5. Provide consultation to various departments on quality systems, regulatory compliance, and risk management.
6. Conduct internal and external audits to ensure compliance with regulatory standards.
7. Lead and oversee post-market surveillance programs.
8. Collaborate with cross-functional teams to drive continuous improvement initiatives.
9. Lead the review and approval of design and process changes, ensuring compliance with quality standards and regulatory requirements.

Qualifications

1. Bachelor\'s degree in Engineering, Quality Assurance, or a related field is required.
2. Minimum of 12 years of experience in a quality engineering role with strong medical device industry experience.
3. Extensive knowledge of FDA regulations, ISO 13485, Fishbone, DMAIC, 8D, and/or FDA QMSR.
4. Expertise in post-market quality system activities including complaint handling, vigilance/adverse event reporting, HHE, and post-market surveillance.
5. Conduct and lead complex investigations and implement CAPA.
6. Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) is preferred.

Interested in hearing more? Easy Apply now by clicking the "Easy Apply" button.

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