Senior Quality Engineer (Full time)

Strictly No C2C



We are seeking an experienced Senior Quality Engineer with a strong background in the medical device industry. The ideal candidate will be well-versed in FDA regulations and ISO 13485 guidelines, with expertise in quality assurance, statistical analysis, and supplier management. This role is critical to ensuring compliance, product quality, and successful design transfer activities.

Key Responsibilities:

1. Regulatory Compliance:

Ensure adherence to FDA regulations and ISO 13485 standards.

Develop and maintain quality system documentation and processes.

2. Verification and Validation (V&V):

Provide V&V support, including planning, execution, and documentation.

Conduct statistical analysis to assess and validate product performance.

Develop and justify sampling plans and rationales.

3. Supplier Quality Management:

Conduct supplier audits and assessments to ensure compliance and capability.

Monitor and report supplier quality performance metrics.

Drive supplier quality improvements and manage supplier corrective actions.

4. Design Transfer and Contract Manufacturing:

Support design transfer activities to ensure product and process compliance.

Collaborate with contract manufacturing partners to maintain quality standards.

Qualifications and Skills:

Bachelor’s degree in Engineering, Quality, or a related field.

Extensive experience in the medical device industry.

In-depth knowledge of FDA regulations and ISO 13485 guidelines.

Proven expertise in statistical analysis, sampling plans, and quality metrics.

Strong background in supplier audits, supplier management, and contract manufacturing.

Excellent problem-solving, analytical, and communication skills.