Quality Assurance Compliance Specialist

ABOUT

Want to work for a fast-paced and disruptive company that is working to revolutionize blood testing? Truvian is a healthcare company at the intersection of diagnostics and consumer tech. We are developing an automated benchtop diagnostic system to provide lab-accurate results in 30 minutes for a comprehensive suite of health tests. Our proprietary approach, for which we are seeking FDA clearance, is intended to fulfill the promise of delivering accessible and affordable blood testing from one small blood sample in minutes in a retail setting or private clinic.

To us, our work at Truvian is more than a job-it's a mission. We are a culture dedicated to discovery and empowerment. We are trailblazers on the path to putting health information where it belongs-in the hands of the individual. We are partners in the belief that talented people working as a team can make every day an adventure. Come join us as we realize our vision to make routine health testing convenient, affordable, and actionable for today's connected consumers!

JOB SUMMARY

Truvian is looking for a Quality Assurance Compliance Specialist as we enter our next evolution phase. In this role, you will be responsible for effectively deploying and ensuring compliance with Truvian's Quality Management System (QMS), such as Design Control, Risk Management, CAPA, NCR, Complaints, Supplier Management, etc., to ensure product quality. Assure Truvian's Quality Management System conforms to FDA Quality Management System Regulation, ISO 13485, and all applicable international regulatory requirements. Understand IVD regulations and ensure Truvian's Quality Management Systems and documentation remain compliant. Work with cross-functional teams to provide quality support, guidance, and direction for all R&D and manufacturing, including driving/managing compliant issues to closure and escalating to senior management for support as necessary. Define, evaluate, prioritize, and correct potential compliant risks to drive continuous quality improvements. This role will report directly to the head of Quality Assurance / Regulatory Affairs.

HERE'S WHY YOU'LL LOVE THIS JOB:

• You will play a vital role as a QA Representative in ensuring the Quality Management System is compliant with the FDA Quality Management System Regulation, ISO 13485, and all applicable international regulatory requirements … There is a lot to do!

• You'll work with a rock-star team of people who are passionate about their work and our ability to disrupt healthcare with our innovative products.

• You'll be a key player on a team responsible for the company's growth and product launch while providing leadership.

• You thrive in a fast-paced and dynamic environment where you can implement fresh ideas and new processes and make things happen quickly without a lot of red tape.

• You'll have great perks: Generous Benefits (Medical/Dental/Vision/EAP/Paid Life Insurance/LTD/401K), paid parental leave, and flexible PTO.

WHAT YOU WILL DO:

Broadly, this role delivers Truvian's diagnostic products into diverse, global end markets. This will require:

• Be a champion for Quality Management System

• Lead the development, implementation, and maintenance of our quality management system, emphasizing industry best practices.

• Ensure compliance with FDA 21 CFR 820 and ISO 13485 requirements.

• Train and monitor the team's compliance with quality

• Lead and participate in internal and external audits, including managing corrective and preventive actions.

• Identify, understand, and document processes and procedures surrounding the Quality Management System.

• Analyze and report on key quality data and trends to identify areas of improvement.

• Collaborate with senior management to identify and mitigate compliant risks.

• Collaborate with cross-functional teams to integrate compliance and quality considerations into business, product development, and operation processes.

• Work closely with various functions to ensure the documentation complies with all applicable regulatory requirements.

• Foster a continuous improvement and accountability culture within the quality team and the organization.

• As needed, support the Head of QA/RA in overseeing Internal and external audits, Corrective and Preventive Actions, Nonconforming materials, and Training.

• Perform quality management review.

• Conduct regular risk assessments and audits to ensure proactive quality management.

• Ensure timely review/assessment of Quality documentation, including Design Control, Process Control, and support for process changes in compliance with QSMR and ISO requirements.

• Support the activities of the Quality Department to meet Company and QA goals and objectives.

• Be a change catalyst that can drive process improvement through strategic influence.

• Represent the organization in quality-related matters with external stakeholders, including customers, suppliers, and regulatory bodies.

• Working with the Head of QA and RA, evaluate post-market processes and services to ensure full QMS compliance.

WHAT YOU WILL BRING:

The ideal candidate will have extensive experience in:

• Experience implementing Quality Management System and ISO 13485.

• A bachelor's degree in a technical, engineering, life sciences, or software discipline is required, or equivalent experience is required.

• In-depth knowledge of FDA 21 CFR 820 and ISO 13485.

• Excellent interpersonal and communication skills with the ability to effectively interface with technical personnel at various levels of the organization.

• Problem-solving, with very strong analytical skills, which can be utilized to proactively identify and address issues with a solution-oriented approach with excellent time management skills

The candidate will have a BA/BS degree and directly related years of experience. A minimum of 5 years of quality experience in IVD. in Quality Assurance, with an emphasis on Quality Management System Regulation and ISO 13485 at both small and large companies.

SUPERVISORY ROLE

• No

SALARY RANGE

$106,000 - $122,000

This range considers the factors considered in making compensation decisions, including but not limited to experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. Salary offers are determined based on the final candidate's qualifications and experience. Placement within the compensation range is determined by internal equity and relevant qualifications.

PHYSICAL DEMANDS AND ABILITIES

• Regularly required to use hands to finger, handle or feel, reach with hands and arms, and talk or hear

• Ability to lift and move over 25 lbs. repeatedly and safely, occasionally 75 lbs. with assistance

• Frequently required to stand, walk, stoop, kneel, crouch or crawl

• Occasionally required to sit and climb or balance

• Specific vision abilities required for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust and focus

If you want to stand out, please include a cover letter

Truvian provides equal employment opportunities to all employees and applicants and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all employment terms and conditions, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.