Quality Assurance Specialist

QUALITY ASSURANCE SPECIALIST Company: VahatiCor Status: Full-time, Nonexempt Location: Onsite, Santa Clara, CA Reports to: Chief Operations Officer Manufacturing ABOUT THE COMPANY VahatiCor is a venture-backed medical technology company developing a new cardiovascular therapy. As the company grows beyond its startup incubator, it is building the quality systems and infrastructure needed to support its next stage. POSITION OVERVIEW The Quality Assurance Specialist will inspect and test materials, components, subassemblies, and finished cardiovascular medical devices. As a member of the Quality team, this person will also carry out material control and nonconformance activities, maintain manufacturing and inspection records, and participate in validation activities. This is a hands‑on role requiring medical device industry experience and the ability to work in compliance with current Good Manufacturing Practices (cGMP), approved procedures, and established quality system requirements. Inspection activities include handling small components and spending extended periods looking through microscopes. This person will work closely with Quality, Manufacturing, and Engineering. Success requires excellent attention to detail, sound judgment, accurate documentation, and a responsive, service‑oriented approach to colleagues. KEY RESPONSIBILITIES Inspection and Testing Perform incoming inspection and testing of medical device materials and components using approved specifications, inspection procedures, and sampling plans. Collect and evaluate quality documentation accompanying incoming materials, including certificates of conformity, supplier inspection records, and other required documentation. Perform in‑process inspection and testing of subassemblies and final inspection of completed medical devices. Inspect materials and products for applicable dimensional, visual, workmanship, labeling, and packaging requirements. Use microscopes for detailed inspection of small components, assemblies, and finished devices, including extended periods of microscope use. Use calipers, micrometers, height gauges, gauge blocks, optical inspection and measurement equipment, and other approved tools appropriate to assigned inspections. Document and communicate inspection results, test results, and nonconformances according to approved quality system procedures and good documentation practices. Work in cleanroom and electrostatic discharge‑protected areas, as applicable, following required procedures for gowning, contamination control, and material handling. Material Control and Nonconformance Activities Carry out material control procedures, including receipt verification, identification, quarantine, and movement of materials to and from Quality. Verify material identification, part numbers, revision levels, lot or serial numbers, quantities, and inspection status against approved documentation. Maintain material control, nonconformance, work order, and serial number logs and databases, as assigned. Identify and document nonconforming materials or products and coordinate their segregation and status labeling to prevent unintended use. Participate in the investigation, disposition, and documentation of nonconforming materials by gathering inspection results, measurements, manufacturing records, and other relevant information. Perform approved reinspection or verification following authorized rework or other disposition decisions. Escalate unresolved discrepancies and recurring defects to the appropriate Quality, Manufacturing, or Engineering personnel. Manufacturing and Quality Records Contribute to and maintain lot records and Device History Records, including required inspection, manufacturing, and traceability information. Review records for completeness, accuracy, legibility, required signatures and dates, and use of current approved document revisions. Identify missing entries, inconsistent information, or incomplete approvals and coordinate correction with the responsible personnel. Follow good documentation practices when recording results or making corrections, preserving original information and required audit trails. Maintain organized records that are readily available for Quality review, product acceptance or release activities, audits, and retention. Inspection Procedures and Measurement Equipment Develop and update inspection procedures, measurement programs, forms, and checklists in coordination with Quality and Engineering and through established document approval procedures. Identify unclear inspection instructions or acceptance criteria and obtain clarification before proceeding. Ensure inspection and measurement equipment is maintained and calibrated as required. Verify equipment calibration status and suitability before use and report damaged equipment, inconsistent readings, or other concerns that could affect results. Maintain inspection tools and work areas according to approved handling, storage, and housekeeping procedures. Validation Activities Participate in the execution of approved process validation and test method validation protocols. Perform assigned activities for installation qualification, operational qualification, and performance qualification (IQ/OQ/PQ), including inspection, measurement, and data collection. Participate in gauge repeatability and reproducibility studies to evaluate consistency of measurements across equipment and operators. Document results accurately and communicate deviations, unexpected findings, or execution questions to the responsible Quality or Engineering personnel. Quality System Compliance and Audits Maintain working knowledge of procedures, specifications, and applicable quality requirements related to assigned responsibilities. Perform assigned inspection, material control, and documentation activities in compliance with cGMP and approved quality system procedures. Serve as a knowledgeable resource for assigned inspection methods, equipment, and records before, during, and after audits or inspections. Retrieve and organize records requested for internal audits, external audits, or regulatory inspections. Participate in visits to and quality audits of contract manufacturers, as assigned, including review of inspection practices and relevant manufacturing and quality records. Complete assigned follow‑up activities arising from audits, inspections, or quality investigations. Cross-Functional Collaboration and Continuous Improvement Coordinate inspection priorities and documentation needs with Quality, Manufacturing, and Engineering. Respond promptly to requests, communicate expected completion times, and raise workload conflicts or potential delays early. Explain discrepancies clearly and respectfully using the applicable requirement and supporting evidence. Handle disagreements and deadline pressures professionally while maintaining quality standards and ethical conduct. Contribute practical suggestions for improving inspection methods, documentation, material controls, and daily workflows. Demonstrate initiative, follow through on commitments, and remain open to feedback, coaching, and continued learning. REQUIRED QUALIFICATIONS High school diploma or equivalent. Minimum of five years of experience in quality inspection, quality specialist, or related manufacturing work in the medical device industry, including experience working in compliance with cGMP. Hands‑on experience using microscopes to inspect small medical device components or assemblies. Experience using precision inspection and measurement equipment, including calipers, micrometers, and other tools appropriate to assigned inspections. Ability to read and interpret mechanical drawings, dimensions, tolerances, inspection specifications, and work instructions. Strong math skills and mechanical aptitude. Excellent attention to detail and the ability to maintain concentration and inspection accuracy during extended periods of microscope use. Strong oral and written communication skills, including legible handwriting for written records. Ability to document results accurately, recognize discrepancies, and follow established escalation procedures. Proficiency with routine computer applications, including email, word processing, spreadsheets, and database entry. Demonstrated ability to work independently within approved procedures while collaborating effectively with colleagues. Ability to manage competing priorities and deadline pressures professionally. Willingness to travel to contract manufacturer facilities for assigned visits, inspections, or quality audits. PREFERRED QUALIFICATIONS Technical training or an associate degree in a related field. Experience inspecting catheter assemblies or other small, precision medical device products. Experience using height gauges, gauge blocks, and optical inspection or measurement equipment. Experience maintaining or reviewing lot records and Device History Records. Experience participating in process validation, test method validation, or gauge repeatability and reproducibility studies. Experience working in cleanroom or electrostatic discharge‑protected environments. Familiarity with electronic quality management, document control, or material tracking systems. Experience in an early‑stage medical device company. WORK ENVIRONMENT AND PHYSICAL REQUIREMENTS This is an onsite position involving work in inspection, manufacturing, and office areas, including cleanroom or other controlled environments as applicable. The work involves handling small medical device components and spending extended periods looking through microscopes to inspect components, assemblies, and finished devices. Essential inspection duties require sustained attention, careful observation, manual dexterity, and accurate measurement. Daily activities may include sitting or standing at inspection workstations, walking between work areas, handling materials and equipment, and using computers to enter and review records. Visits to contract manufacturers may be required for assigned inspections or quality audits. Overtime may be required based on workload and business needs. ELIGIBILITY Candidates must be permanently authorized to work in the United States without the need for current or future visa sponsorship. We are currently unable to sponsor employment visas or permanent residency applications. #J-18808-Ljbffr