We have a current opportunity for a Quality Specialist Advert - Irvine/ San Diego on a contract basis.
Job Title: Quality Specialist Consultant
Job Type: Full-time
Location: California, Irvine/San Diego
Type: Artificial Cardiac Pacemaker
Job Description:
We are looking for a Quality Specialist Consultant to join our team. The ideal candidate will have experience in the medical device industry and be familiar with quality management systems and regulatory requirements.
Responsibilities:
- Develop and implement quality management systems to ensure compliance with regulatory requirements such as 21 CFR Part 820.
- Conduct internal audits to assess compliance with quality management systems and identify areas for improvement.
- Provide guidance and support to cross-functional teams on quality-related issues.
- Participate in the development of new products and processes to ensure compliance with regulatory requirements and maintain a Design History File (DHF).
- Develop and maintain quality metrics to monitor performance and identify areas for improvement.
- Participate in external audits and inspections as needed.
Requirements:
- Bachelor's degree in engineering, life sciences, or related field.
- Minimum of 5 years of experience in the medical device industry.
- Experience with quality management systems and regulatory requirements such as Corrective and Preventive Action (CAPA).
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
