QA Specialist
QA Specialist
Posted on :
26-05-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
26-05-2025
Job Description
Job title:QA Specialist
Job statement: As a QA Specialist you will play a critical role in implementing and maintaining the company quality management system (QMS) to ensure compliance with relevant regulatory standards and guidelines such as ISO 13485 and FDA regulations.
Location: Santa Barbara CA (On-site required)
About us
Aptitude Medical Systems is a startup deep-tech healthcare company. Our mission is democratizing diagnostics by empowering individuals to access their health and diagnostic information anytime anywhere. Aptitude created a simple accurate and easy-to-use diagnostic platform that fits in the palm of the hand and allows anyone to run a complex lab-quality PCR test in their own hands in minutes. Aptitudes lead products Metrix COVID-19 Test and COVID/Flu Test are FDA-authorized molecular diagnostic tests to work with swab samples for at-home and over-the-counter use without physician supervision and we have a product pipeline that includes tests fora wide range ofhealth and wellness conditions. Imagine being able to consult your doctor run the diagnostic tests you need and get a prescriptionwithout having to leave your home. Thats the future were building. Come join us!
About the role
We are seeking a meticulous and knowledgeable Medical Device Quality Assurance (QA) Specialist to ensure the safety efficacy and compliance of our medical device products. The QA Specialist will play a critical role in implementing and maintaining quality management systems conducting thorough testing procedures and adhering to regulatory requirements. The ideal candidate will have a strong background in medical device QA excellent attention to detail and a commitment to upholding the highest standards of quality and safety in healthcare.
The work location for this position is Santa Barbara California - an idyllic location offering immense natural beauty outdoor adventure big city amenities in a mid-sized town and easy access to Californias metropolitan centers.
Responsibilities
Job statement: As a QA Specialist you will play a critical role in implementing and maintaining the company quality management system (QMS) to ensure compliance with relevant regulatory standards and guidelines such as ISO 13485 and FDA regulations.
Location: Santa Barbara CA (On-site required)
About us
Aptitude Medical Systems is a startup deep-tech healthcare company. Our mission is democratizing diagnostics by empowering individuals to access their health and diagnostic information anytime anywhere. Aptitude created a simple accurate and easy-to-use diagnostic platform that fits in the palm of the hand and allows anyone to run a complex lab-quality PCR test in their own hands in minutes. Aptitudes lead products Metrix COVID-19 Test and COVID/Flu Test are FDA-authorized molecular diagnostic tests to work with swab samples for at-home and over-the-counter use without physician supervision and we have a product pipeline that includes tests fora wide range ofhealth and wellness conditions. Imagine being able to consult your doctor run the diagnostic tests you need and get a prescriptionwithout having to leave your home. Thats the future were building. Come join us!
About the role
We are seeking a meticulous and knowledgeable Medical Device Quality Assurance (QA) Specialist to ensure the safety efficacy and compliance of our medical device products. The QA Specialist will play a critical role in implementing and maintaining quality management systems conducting thorough testing procedures and adhering to regulatory requirements. The ideal candidate will have a strong background in medical device QA excellent attention to detail and a commitment to upholding the highest standards of quality and safety in healthcare.
The work location for this position is Santa Barbara California - an idyllic location offering immense natural beauty outdoor adventure big city amenities in a mid-sized town and easy access to Californias metropolitan centers.
Responsibilities
- Develop and implement quality assurance processes and procedures to monitor and evaluate the quality of medical devices.
- Establish and maintain documentation control processes to ensure accurate and up-to-date quality documentation.
- Review approve and maintain QMS records including production history & lot release training supplier and technical report records.
- Review approve and maintain design control documentation including design inputs outputs verification and validation protocols/reports.
- Collaborate closely with cross-functional teams including R&D engineering manufacturing regulatory affairs and clinical affairs to ensure quality objectives are met throughout the product lifecycle.
- Investigate and analyze product non-conformances complaints and adverse events and implement corrective and preventive actions (CAPAs) as necessary.
- Provide training and support to employees on quality management systems regulatory requirements and quality assurance processes.
- Evaluate qualify and monitor suppliers and service providers to ensure they meet quality and regulatory requirements and implement corrective actions as necessary to address any issues or deficiencies.
- Stay informed about changes in regulations standards and best practices in the medical device industry and implement necessary updates to quality systems and processes.
Qualifications
- Humble transparent and embodying a team-first attitude.
- Reliable meticulous and hard-working.
- Independent resourceful and self-motivated.
- Strong analytical and problem-solving skills with the ability to interpret complex technical information and regulatory requirements.
- Excellent communication and interpersonal skills with the ability to collaborate effectively with cross-functional teams and external stakeholders.
- Detail-oriented mindset with a focus on accuracy thoroughness and compliance with quality standards and regulations.
- Minimum of Bachelor of Science Degree in Biomedical Mechanical Engineering or Engineering Technology.
- Proficient computer skills including MS Word PowerPoint and Excel.
- Experience with electronic quality management systems (eQMS) and document control software is a plus.
Benefits
- Competitive compensation.
- Growth opportunities inherent to a fast-growing startup.
- 401K Plan with company matching.
- Medical insurance including medical dental and vision coverage.
- Flexible paid time off.
- Immigration support.
Aptitude Medical Systems is an equal opportunity employer and is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin gender age sexual orientation physical or mental disability genetic information or characteristic gender identity and expression veteran status or any other consideration made unlawful by federal state or local law.
Required Experience:
Junior IC
Employment Type
Full-Time
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