Senior Quality Engineer
San Diego, CA
Full Time
Experienced
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 of less 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
The Sr. Quality Engineer, role will provide quality oversight in ensuring smooth manufacturing operation, new product launches/transfers in a compliant/timely manner, ensure manufacturing is in full GMP compliance, and ensure quality strategy/continuous improvement is driven in alignment Truvian’s objectives and goals. In this role, you will leverage both your technical breadth and business acumen to maintain the design integrity of commercially available products.
This role requires a strong technical background to provide technical support to operating departments in statistical applications, process capability assessment, and problem-solving. Active participation in project teams to improve existing processes and raw material handling systems is expected. The role must understand the needs of internal and external customers, then translate and implement these requirements into total manufacturing support, including product/process improvements. Experience in IVD is highly desired and a plus. This is an on-site position reporting to the Head of QA/RA.
WHAT YOU WILL DO:
SALARY RANGE
$ 121,000 to $135,000 Annually
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 the final candidate's qualifications and experience. Placement within the compensation range is determined by internal equity and relevant qualifications.
SUPERVISORY ROLE
No
WORK LOCATION
Onsite
FLSA STATUS
Exempt
PHYSICAL DEMANDS AND ABILITIES
If you want to stand out, please include a cover letter
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.
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 of less 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
The Sr. Quality Engineer, role will provide quality oversight in ensuring smooth manufacturing operation, new product launches/transfers in a compliant/timely manner, ensure manufacturing is in full GMP compliance, and ensure quality strategy/continuous improvement is driven in alignment Truvian’s objectives and goals. In this role, you will leverage both your technical breadth and business acumen to maintain the design integrity of commercially available products.
This role requires a strong technical background to provide technical support to operating departments in statistical applications, process capability assessment, and problem-solving. Active participation in project teams to improve existing processes and raw material handling systems is expected. The role must understand the needs of internal and external customers, then translate and implement these requirements into total manufacturing support, including product/process improvements. Experience in IVD is highly desired and a plus. This is an on-site position reporting to the Head of QA/RA.
WHAT YOU WILL DO:
- This position will report directly to the Head of QA/RA.
- Ensure compliance with all relevant FDA 21 CFR 820, Design Control, Risk Management ISO 14971, ISO 13485 regulatory requirements, and internal Quality Standards for product development and manufacturing. Creates and applies policies and procedures for identifying, analyzing, and controlling risk throughout the product life cycle.
- Designs and installs quality process sampling systems, procedures, and statistical techniques.
- Conducts training and supervises other engineers and inspection personnel in the execution of Quality tasks.
- Promotes success through the development of methods and arguments for achieving company objectives while adhering to Quality/Regulatory requirements.
- Actively represent Quality Assurance function on product/process development teams.
- Hands on participant in early stages of product development including but not limited to product engineering, competitive product testing, prototype development, and prototype testing.
- 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. Ensure successful transfer of new products to the production facility by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques.
- Interact with component suppliers on product development projects and quality issues.
- Establish, implement, and validate inspection plans, equipment, and procedures.
- Develops quality inspection criteria for incoming inspection and final inspection.
- In this role, you will leverage both your technical breadth and business acumen to maintain the design integrity of commercially available products
- Review and approve deviations, CAPAs, SOPs, and Change Control related to manufacturing operations
- Capture and implement manufacturing "best practices"; ensure root cause analysis
- Perform/assist with quality investigations of manufacturing deviations, GMP and Quality System issues, non-conforming materials, and CAPA, as needed
- Serve as Subject Matter Expert on batch record review and material/product release processes
- Author, revise, review/approve SOPs, Forms, Training materials, and other GMP documentation
- Gather metric information for use in continuous improvement of areas of responsibility, as needed
- Collaborate with a cross-functional team from Manufacturing, Supply Chain, QC, Facilities/Engineering, and other QA functions
- Support and lead cross-functional projects and Quality initiatives
- Lead the quality assessment for product lifecycle changes, efficiency projects, and continuous improvement projects.
- Support supplier and internal audits as necessary.
- Bachelor’s degree with a minimum of 10+ years of experience; Master’s degree with a minimum 8 years of experience; or PhD with 2 years of experience, in IVD industry.
- Advanced familiarity with IVD and biotech product development and manufacturing processes.
- Experience with successful IVD system development and commercialization.
- Strong familiarity with both reagents and instrument platforms, Manufacturing Processes, and assay integration is strongly preferred.
- Experience in Quality System Requirements and EQMS.
- Experience with operation and post-launch product support with an emphasis on reliability design, testing, and tracking.
- Solid analytical skills with an eye for detail to assess the impact of multiple variables on product performance.
- Skilled in systems thinking with a range of knowledge and experience in:
- system verification and test protocol creation
SALARY RANGE
$ 121,000 to $135,000 Annually
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 the final candidate's qualifications and experience. Placement within the compensation range is determined by internal equity and relevant qualifications.
SUPERVISORY ROLE
No
WORK LOCATION
Onsite
FLSA STATUS
Exempt
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 10 lbs.
- Frequently required to stand, walk, stoop,
- Occasionally required to sit and climb
- 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 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.
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