Quality Assurance Technician

QUALITY ASSURANCE TECHNICIAN

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 Technician 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 technician 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.

LOCATION AND COMPENSATION

This is an onsite position based at VahatiCors headquarters in Santa Clara CA. We are prioritizing candidates who currently reside within a reasonable commute distance from our office but candidates willing to relocate may be considered with limited relocation assistance potentially available.

The anticipated hiring pay range for this position is $71000 - $84000 annuallly. Actual compensation will be determined based on experience qualifications geographic location and other job-related factors. VahatiCor is committed to fair and equitable pay practices. The total compensation package may also include bonus opportunities equity and company-sponsored benefits.

EQUAL OPPORTUNITY

VahatiCor is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Employment decisions are based on qualifications merit and business needs. We do not discriminate based on race color religion sex sexual orientation gender identity national origin disability veteran status or any other protected characteristic.

THIRD-PARTY RECRUITER NOTICE

We do not accept unsolicited resumes from staffing agencies or recruiters without a signed agreement in place. Any resumes submitted without such an agreement will be considered the property of VahatiCor and no fees will be paid if the candidate is hired. Agencies interested in submitting candidates may email

Required Experience:

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