Sr. Quality Engineer Jobs

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 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 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. Come 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

• Participate in development, review and approval of product requirements, product specifications, test protocols and reports. Review new and modified product design for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirement
• Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of IVD or Medical Device product.
• Lead and support internal, third party and supplier audits.
• Ability to work independently, with minimal supervision
• Conduct evaluations, tests, verifications, validations and makes decisions to maintain compliance to Quality Management System, applicable regulations and standards.
• Preparation of data analyses and recommendation for actions.
• Interact with suppliers during audits, qualifications, evaluations, and monitoring activities.
• Conduct product investigations, root cause analysis, and implementation of corrections and preventative actions.
• Other duties as assigned by management.
• Excellent communication skills
• Coordinate, review and manage non-conformances. Communicate with suppliers and other functions internally to troubleshoot issues. Create and reviews SCARs.
• Utilize a constructively assertive approach that reaches out, speaks up, and drives continuous improvement.
• Actively represent Quality Assurance function on product/process development teams, ensure compliance to design control process.
• Develop, establish and implement quality plans, validation and inspection plans.
• Hands on participant in early stages of product development.
• Train other employees on quality management system processes.
• Ensure successful transfer of new products to production by assisting in the development of process validation using appropriate statistical tools and techniques.
• Ensure compliance with all relevant FDA 21 CFR 820, Design Control, Risk Management ISO 14971, ISO 13485 regulatory requirements for product development and manufacturing.
• Consistently demonstrates “above the line” behaviors in the day-to-day execution of job duties.
• Plan, develop and conduct capability studies for production processes.
• Lead 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.

What You Will Bring
Extensive experience in:

• Advanced familiarity with IVD and biotech product development and manufacturing processes
• Ability to handle and resolve conflicts and work under schedule/milestone pressures
• Experience with eQMS and ERP
• Organizational, planning and detail follow-up skills required
• 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
• 8 years’ experience in quality engineering in the IVD or Medical Device industry at both small and large organizations
• Experience in Quality System Requirements
• Strong analytical skills and effective problem-solving ability
• Minimum B.S. in engineering, life science or related discipline
• Risk analysis technique, FMEA, Fault tree, and Hazard Analysis
• Excellent written and verbal communication skills
• Ability to work in a multi-functional team environment
• Experience with Medical Device Software Design and Development Cycle is a plus

SUPERVISORY ROLE

• No

SALARY RANGE
$110,000 to $130,000
This range considers the wide range of factors that are 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 final candidate 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

• Specific vision abilities required for this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust and focus
• 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
• Occasionally required to sit and climb or balance
• Frequently required to stand, walk, stoop, kneel, crouch or crawl

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.