Senior Quality Engineer

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 20 minutes for a comprehensive suite of health tests. Our proprietary approach, for which we are seeking FDA clearance, is 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.

Our work at Truvian is more than a job - It is a mission. We are a culture dedicated to discovery and empowerment. We are trailblazers on the path to put 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. Join us as we realize our vision to make routine health testing convenient, affordable, and actionable for today's connected consumers!

JOB SUMMARY

Senior Quality Engineer will support R&D, Design Transfer, and V&V efforts focusing on developing new blood diagnostics tests. This role will report directly to the Sr Director, Quality.

WHAT YOU WILL DO:

• Ensure compliance with all relevant FDA 21 CFR 820, Design Control, Risk Management ISO 14971, ISO 13485 regulatory requirements for product development and manufacturing.

• Led the product development team through the risk analysis process, including product hazard analysis, DFMEA, PFME, risk-benefit analysis, and risk management planning and reporting supporting compliance with ISO14971 throughout the product life cycle.

• Actively represent the Quality Assurance function on product/process development teams, ensuring compliance with the design control process.

• Direct participant in initial stages of product development.

• Participate in the development, review, and approval of product requirements, product specifications, test protocols, and reports. Review new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.

• Develop, establish, and implement quality, validation, and inspection plans.

• Ensure the successful transfer of new products to production by assisting in developing process validation using appropriate statistical tools and techniques.

• Conduct evaluations, tests, verifications, and validations and made decisions to maintain compliance with the Quality Management System, applicable regulations, and standards.

• Lead and support internal, third-party, and supplier audits.

• Coordinate, review, and manage non-conformances. Communicate with suppliers and other internal functions to troubleshoot issues. Create and review SCARs.

• Conducted product investigations and root cause analysis and implemented corrections and preventative actions.

• Interact with suppliers during audits, qualifications, evaluations, and monitoring activities.

• Train other employees on quality management system processes.

• Planned, developed, and conducted capability studies for production processes.

• Preparation of data analyses and recommendations for actions.

• Maintain knowledge of current regulatory requirements and standards for developing and releasing IVD or Medical Device products.

• Consistently demonstrates "above the line" behaviors in the day-to-day execution of job duties.

• Ability to work independently, with minimal supervision.

• Excellent communication skills

• Utilize a constructively assertive approach that reaches out, speaks up, and drives continuous improvement.

• Other duties as assigned by management.

WHAT YOU WILL BRING:

Extensive experience in:

• Minimum B.S. in engineering, life science, or a related discipline

• 8 years experience in quality engineering in the IVD or Medical Device industry at both small and large organizations

• Advanced familiarity with IVD and biotech product development and manufacturing processes

• Experience in Quality System Requirements

• Experience with eQMS and ERP

• Experience with Medical Device Software Design and Development Cycle is a plus

• Strong analytical skills and practical problem-solving ability

• Risk analysis technique, FMEA, Fault tree, and Hazard Analysis

• Organizational, planning, and detailed follow-up skills required

• Excellent written and verbal communication skills

• Ability to work in a multi-functional team environment

• Ability to handle and resolve conflicts and work under schedule/milestone pressures

• Demonstrated ability to lead fast-track investigations through analysis to outcomes for decision

• Demonstrated ability to be flexible and resourceful. Good communication and diplomacy skills required

SUPERVISORY ROLE

• No

SALARY RANGE

$110,000 to $125,000

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.

FLSA

• Exempt

WORK LOCATION

• Onsite

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

Truvian provides equal employment opportunities to all employees and applicants for employment 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 terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.