Quality Control Technician

Van Nuys             ·           Full time

Quality Control Technician

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Job Description:

AppliedVR is looking for a mission-driven Quality Technician with a passion for transforming healthcare through innovative technology, to support Regulatory Affairs and Quality Assurance – RA/QA department.

Reporting to the Director of Quality Assurance and working closely with multiple stakeholders, the Quality Technician will have a minimum of 3 years of hands-on experience in the medical device industry. As a Quality Technician, you will play a critical role in ensuring the highest standards of quality and compliance are met throughout our organization’s medical device manufacturing processes. Your primary responsibility will be to perform various quality control activities, inspections, and tests to ensure product safety, reliability, and adherence to regulatory requirements. A successful candidate will possess strong attention to detail, excellent analytical skills, and a thorough understanding of quality assurance principles within the medical device field.

This position is required to be in-person in our Van Nuys facility. Typical hours between 6:30am – 2:30pm.

Roles & Responsibilities (are not limited to the following):

• Perform incoming, in-process, and final inspections of medical devices, components, and raw materials to verify compliance with established specifications, quality standards, and regulatory requirements
• Conduct product and process audits to ensure adherence to Good Manufacturing Practices (GMP), ISO standards, and other applicable regulations
• Collaborate with cross-functional teams, including manufacturing, engineering, product and regulatory affairs, to identify and resolve quality issues, process improvements, and corrective actions
• Utilize various measuring and testing equipment, such as calipers, micrometers, gauges, and optical inspection systems, to conduct accurate and reliable inspections and tests
• Document and maintain detailed records of inspection results, non-conformances, and corrective actions taken, ensuring compliance with documentation procedures and regulatory requirements
• Participate in the development and implementation of quality control procedures, work instructions, and quality assurance processes to enhance product quality and efficiency
• Participate in root cause analysis and contribute to the implementation of effective corrective and preventive actions (CAPAs) to address quality issues and improve overall quality performance
• Provide training and guidance to production personnel on quality control procedures, quality standards, and best practices to promote a culture of quality awareness and continuous improvement
• Stay updated on industry standards, regulatory requirements, and emerging trends in the medical device field to ensure compliance and identify opportunities for process and quality enhancements
• Support internal and external audits, inspections, and regulatory submissions by providing necessary documentation, data, and expertise
• Support the validation and qualification activities for manufacturing processes, equipment, and software systems, ensuring compliance with regulatory requirements and industry standards

Experience Qualifications:

• Minimum of 3 years of experience as a Quality Technician in the medical device industry
• Associate’s Degree in a field related to quality assurance, quality control, or a relevant discipline in the medical field or relevant work experience
• In-depth knowledge of quality assurance principles, regulatory requirements, and industry standards applicable to medical devices (e.g., FDA regulations, ISO 13485)
• Strong understanding of manufacturing processes, inspection techniques, and statistical analysis tools commonly used in the medical device industry
• Proficiency in utilizing measuring and testing equipment such as calipers and micrometers.
• Excellent analytical skills with the ability to identify, troubleshoot, and resolve quality issues effectively
• Possess a solid understanding of root cause analysis and CAPA methodologies to drive continuous improvement and experience with conducting product analysis; prior participation in process audits and inspections; familiarity with risk management processes, including hazard analysis and risk assessment, is a plus
• Detail-oriented mindset with strong organizational and documentation skills
• Effective communication and interpersonal skills, with the ability to collaborate cross-functionally and communicate complex quality-related concepts to diverse stakeholders
• Relevant certifications (e.g., Certified Quality Technician, ASQ) are highly desirable

Compensation:

$65k to $95k USD Annually

Please note that the compensation provided in this posting does not include any bonus or equity that this role may be eligible for. This role is eligible for our competitive benefits package. Individual compensation packages are based on a few different factors unique to each candidate, including their skills, experience qualifications and other job-related reasons.

Location:

Van Nuys, Los Angeles, CA with hours in the facility from 6:30am – 2:30pm

Our Thoughts on Diversity:

We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates without regard to race color, religion, sex, pregnancy (including childbirth, lactation and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law. AVR believes that diversity and inclusion among our teammates is critical to our success as a global company, and we seek to recruit, develop and retain the most talented people from a diverse candidate pool.

Americans with Disabilities Act Compliance Statement:

To comply with the American with Disabilities Act and other applicable laws ensuring equal employment opportunities to qualified individuals with a disability, reasonable accommodations are made for the known physical or mental limitations of an otherwise qualified individual with a disability unless such accommodations create an undue hardship on AVR.

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