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Quality Engineer III
- Posted 24 January 2025
- LocationCerritos
- Job type Permanent
- Reference210212
- Contact NameJeremy Burling
Job description
About the Role:
My client seeks a highly motivated Quality Engineer III to join our team. You will play a critical role in ensuring the quality and compliance of their class III implantable device throughout its lifecycle. This involves collaborating with cross-functional teams, implementing and maintaining the Quality Management System, and driving continuous improvement initiatives.
Key Responsibilities:
My client seeks a highly motivated Quality Engineer III to join our team. You will play a critical role in ensuring the quality and compliance of their class III implantable device throughout its lifecycle. This involves collaborating with cross-functional teams, implementing and maintaining the Quality Management System, and driving continuous improvement initiatives.
Key Responsibilities:
- Lead and execute quality activities related to product design, development, and manufacturing.
- Ensure compliance with relevant regulations (e.g., ISO 13485, 21 CFR 820).
- Conduct inspections, investigations, and risk assessments.
- Develop and maintain quality documentation (e.g., SOPs, WIs, FMEAs).
- Collaborate with suppliers to ensure quality standards are met.
- Participate in audits and regulatory submissions.
- Mentor junior team members and drive continuous improvement initiatives.
- Bachelor's degree in Biomedical Engineering or related field.
- 8+ years of experience in medical device quality assurance, with at least 5 years in a Class II or III environment.
- Strong understanding of quality systems, regulations, and risk management principles.
- Excellent communication, problem-solving, and analytical skills.
- Experience with statistical analysis, data analysis, and root cause analysis.
- Proficiency in Microsoft Office Suite.
- Experience with statistical software (e.g., Minitab) is a plus.
- Relevant certifications (e.g., CQE, CRE) are a plus.
