Lead Quality Assurance Engineer
1 week ago
Join a dynamic and innovative organization that is transforming the landscape of blood diagnostics. Truvian Sciences is at the forefront of healthcare technology, developing an automated benchtop diagnostic system that delivers lab-quality results in just 20 minutes for a wide range of health assessments. Our unique approach aims to make blood testing accessible and affordable, providing results from a single small sample in minutes, whether in retail environments or private clinics.
At Truvian, we are driven by a mission to empower individuals with their health information. Our culture fosters discovery and collaboration, believing that talented teams can turn every day into an exciting journey. Be part of our vision to make routine health testing convenient, affordable, and actionable for today's connected consumers.
JOB SUMMARY
The Lead Quality Assurance Engineer will play a pivotal role in supporting Research & Development, Design Transfer, and Verification & Validation initiatives focused on the creation of new blood diagnostic tests. This position will report directly to the Senior Director of Quality.
KEY RESPONSIBILITIES:
- Ensure adherence to all applicable FDA 21 CFR 820 regulations, Design Control, and Risk Management ISO 14971, ISO 13485 standards throughout product development and manufacturing processes.
- Guide the product development team through comprehensive risk analysis, including product hazard assessments, DFMEA, PFMEA, risk-benefit evaluations, and risk management documentation, ensuring compliance with ISO 14971 during the product lifecycle.
- Actively represent the Quality Assurance function within product and process development teams, ensuring strict compliance with design control protocols.
- Engage in the early stages of product development as a key participant.
- Contribute to the formulation, review, and approval of product requirements, specifications, testing protocols, and reports. Assess new and modified product designs for quality attributes, including manufacturability, serviceability, testability, reliability, and compliance with product requirements.
- Develop, implement, and oversee quality, validation, and inspection strategies.
- Facilitate the successful transition of new products to production by aiding in the development of process validation using relevant statistical methodologies.
- Conduct evaluations, tests, verifications, and validations, making informed decisions to ensure compliance with the Quality Management System and applicable regulations.
- Lead and support internal, third-party, and supplier audits.
- Manage non-conformance issues, coordinating with suppliers and internal teams to troubleshoot problems and create and review SCARs.
- Conduct product investigations and root cause analyses, implementing corrective and preventive actions.
- Engage with suppliers during audits, qualifications, evaluations, and monitoring activities.
- Provide training to other employees on quality management system processes.
- Plan, develop, and execute capability studies for production processes.
- Prepare data analyses and actionable recommendations.
- Maintain up-to-date knowledge of current regulatory requirements and standards for the development and release of IVD or Medical Device products.
- Consistently demonstrate proactive behaviors in daily job execution.
- Work independently with minimal supervision.
- Exhibit excellent communication skills.
- Adopt a constructively assertive approach that encourages open dialogue and drives continuous improvement.
- Perform other duties as assigned by management.
Extensive experience in:
- Bachelor's degree in engineering, life sciences, or a related field.
- 8 years of experience in quality engineering within the IVD or Medical Device sector, encompassing both small and large organizations.
- Advanced knowledge of IVD and biotech product development and manufacturing processes.
- Experience with Quality System Requirements.
- Familiarity with eQMS and ERP systems.
- Experience with Medical Device Software Design and Development Cycle is advantageous.
- Strong analytical capabilities and practical problem-solving skills.
- Proficiency in risk analysis techniques, including FMEA, Fault Tree Analysis, and Hazard Analysis.
- Exceptional organizational, planning, and detail-oriented follow-up skills.
- Excellent written and verbal communication abilities.
- Ability to thrive in a multi-functional team environment.
- Capability to manage and resolve conflicts while working under pressure.
- Proven ability to lead rapid investigations through analysis to actionable outcomes.
- Demonstrated flexibility and resourcefulness, along with strong communication and diplomacy skills.
• None
SALARY RANGE:
$110,000 to $125,000
This range reflects the factors considered in making compensation decisions, including experience, skills, knowledge, abilities, education, licensure, certifications, and other organizational needs. Salary offers are determined based on the final candidate's qualifications and experience. Placement within the compensation range is guided by internal equity and relevant qualifications.
FLSA:
• Exempt
WORK LOCATION:
• Onsite
PHYSICAL DEMANDS AND ABILITIES:
- Regularly required to use hands for various tasks, reach with hands and arms, and communicate verbally.
- Ability to lift and move over 25 lbs. repeatedly and safely, occasionally up to 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 role include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
This policy applies to all employment terms and conditions, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
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