Sr. Quality Engineer
San Diego Metropolitan Area
Salary Range: $130,000-180,000 + 10% Bonus + Pre-IPO Equity
Our client is an up and coming medical device company specializing in cutting-edge cardiology products that improve patient outcomes and enhance lives. They have multiple products in development right now and their leading product is focused on a wearable device that uses AI for Arrhythmia Detection. With hopes of commercializing their device in early 2025 you will have the opportunity to join right before this company experience explosive growth. Given this company offers pre-IPO equity it can also be a very lucrative next step in your career. If interest in learning more don't hesitate to apply.
Responsibilities:
- Ensure compliance with applicable regulatory requirements (FDA, ISO 13485, and CE Marking).
- Develop, implement, and maintain quality plans, procedures, and controls.
- Support internal and external audits and assist in audit preparation and responses.
- Ensure compliance with Design Controls, Risk Management, and CAPA processes.
- Provide quality engineering support throughout the design and development process.
- Review and approve design inputs, outputs, verification, and validation documentation.
- Participate in design reviews, ensuring that quality and regulatory requirements are met.
- Conduct risk analysis (FMEA, DFMEA, PFMEA) and contribute to risk management activities.
- Collaborate with manufacturing teams to ensure robust production processes.
- Implement process controls and statistical methods (SPC, DOE) to monitor and improve product quality.
- Lead investigations into non-conformances and implement corrective and preventive actions (CAPA).
- Drive continuous improvement initiatives to enhance product quality, reliability, and manufacturability.
- Oversee test method validation, process validation (IQ/OQ/PQ), and equipment qualification.
- Review and analyze test data to ensure product meets performance and safety criteria.
- Develop, validate, and implement inspection methods to ensure consistent product quality.
- Maintain and update quality documentation such as test protocols, validation reports, and standard operating procedures (SOPs).
- Prepare and present quality reports to management and cross-functional teams.
- Ensure proper documentation and traceability throughout the product lifecycle.
Qualifications:
- Bachelor’s degree in Engineering (Mechanical, Biomedical, Electrical, or related field).
- 3+ years of experience in quality engineering within the medical device industry, preferably with cardiology-focused products.
- In-depth knowledge of FDA regulations, ISO 13485
What We Offer:
- 5 Weeks PTO
- Health Care Covered 100% by the company.
- Paid Lunches on the day you work in office.
- Company sponsored team building activities. Such as Pirates games and more!
