Senior Quality Assurance Engineer

2 weeks ago

California, United States EPM Scientific Full time
About the Role

We are seeking a highly skilled Senior Quality Assurance Engineer to join our team at EPM Scientific. As a Senior Quality Assurance Engineer, you will play a critical role in ensuring the quality and compliance of our medical device products.

Key Responsibilities
  • Regulatory Compliance: Ensure that our products meet all applicable regulatory requirements, including FDA, ISO 13485, and CE Marking.
  • Quality Planning: Develop, implement, and maintain quality plans, procedures, and controls to ensure the highest level of quality.
  • Audit Support: Support internal and external audits, and assist in audit preparation and responses.
  • Design Controls: Ensure compliance with Design Controls, Risk Management, and CAPA processes.
  • Quality Engineering Support: Provide quality engineering support throughout the design and development process.
  • Documentation Review: Review and approve design inputs, outputs, verification, and validation documentation.
  • Design Reviews: Participate in design reviews to ensure that quality and regulatory requirements are met.
  • Risk Analysis: Conduct risk analysis (FMEA, DFMEA, PFMEA) and contribute to risk management activities.
  • Process Improvement: Collaborate with manufacturing teams to ensure robust production processes, and implement process controls and statistical methods (SPC, DOE) to monitor and improve product quality.
  • Non-Conformance Investigations: Lead investigations into non-conformances and implement corrective and preventive actions (CAPA).
  • Test Method Validation: Oversee test method validation, process validation (IQ/OQ/PQ), and equipment qualification.
  • Test Data Analysis: Review and analyze test data to ensure product meets performance and safety criteria.
  • Inspection Methods: Develop, validate, and implement inspection methods to ensure consistent product quality.
  • Quality Documentation: Maintain and update quality documentation such as test protocols, validation reports, and standard operating procedures (SOPs).
  • Quality Reporting: Prepare and present quality reports to management and cross-functional teams.
  • Documentation and Traceability: Ensure proper documentation and traceability throughout the product lifecycle.
Requirements
  • Education: Bachelor's degree in Engineering (Mechanical, Biomedical, Electrical, or related field).
  • Experience: 3+ years of experience in quality engineering within the medical device industry, preferably with cardiology-focused products.
  • Knowledge: In-depth knowledge of FDA regulations, ISO 13485.
What We Offer
  • Competitive Salary
  • 5 Weeks PTO
  • Health Care Covered 100%
  • Paid Lunches
  • Company Sponsored Team Building Activities

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