At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives.
We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day: “What would I do if this patient were my mom?” That question drives everything we do.
But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare—driven by innovation, compassion, and purpose.
Join us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins.
Position Summary
The Process Quality Engineer ensures on-going product quality through continuous process and product monitoring, statistical analysis, and continual quality improvement initiatives.
The Process Quality Engineer is primarily responsible for the development and implementation of methods and procedures for process control, process improvement, testing and inspection to ensure that the products continue to meet design and product specifications. This role also performs statistical analysis to maintain quality levels and minimize defects and failure rates, including on-going review of Quality Control testing for material release and resulting data to determine trends and recommend corrective actions. The Process Quality Engineer coordinates activities of the Material Review Board (MRB) and ensures appropriate material dispositions. The role collaborates as necessary, with operational stakeholders on quality problems, ensures that effective corrective actions are implemented and contributes to Operations Quality improvement programs.
Job Responsibilities
Work closely with operations and the business functions to ensure quality performance of product and processes.
Collaborates with Divisional QA, cross-functional groups, and supplier teams to address quality issues.
Support implementation and/or verification of material and/or equipment specifications.
Reviews incoming inventory material receiving records, and quality control testing documentation to release the materials for production use
Accountable for Material and Product releases through review and release of kit manufacturing and batch manufacturing records
Support execution of PFMEA, DFMEA and SOP generation associated with design transfers and product launch
Support execution and analysis of manufacturing related complaints and product field actions.
Execute internal quality deliverables associated with operational changes, manufacturing transfers and supplier-initiated changes.
Participates and may lead change control management; creation and/or review of new or modified procedures.
Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating appropriate actions as necessary.
Own or support identified internal NCs, Deviations, Quality events, CAPAs, and manage to timely root cause investigation, implementation and closure.
Work to introduce and implement Six sigma, process improvement, statistical and problem-solving tools and methodologies
Support the development and review of production processes and for feedback through Measurement System Analysis (MSA) using DMAIC and tools.
Applies statistical methods of analysis and process control to current operations.
Develop understanding of risk management practices and concepts and applies knowledge to manufacturing operations.
Responsible for initiation, internal containment, communication, and support of Commercial Holds for potential product escapes.
Ensure adherence to GMP and safety procedures.
Required Qualifications
Bachelor's degree in engineering/science or related discipline with 2+ years’ experience in a regulated environment OR High School diploma with 5+ years of experience in a regulated environment.
Demonstrated knowledge of quality assurance principles.
Demonstrated knowledge of improvement and statistical tools/methods used within process excellence activities.
Good knowledge of quality control and monitoring methodologies.
Experience in executing problem solving techniques related to manufacturing/design technical issues.
Proven ability to drive and develop improvement of critical business metrics.
Preferred Qualifications
High School Diploma with 8+ years’ experience in a regulated environment, or Bachelors degree with 5+ years’ experience, or Master’s Degree with 2+ years’ experience.
A minimum of 2 years of experience working within FDA regulated (Medical Device, Pharmaceutical) highly preferred and/or regulated industries (Automotive, Aerospace) preferred.
Experience in change management, as well as ensuring assets are appropriately addressed to remain in a validated state.
A Green Belt Certification in Six Sigma or similar certification preferred.
Demonstrated organizational, interpersonal, oral and written skills.
Physical Demands
Employee may be required to lift routine office supplies and use standard office equipment.
Ability to sit for extended periods of time.
Majority of work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the data center, fumes and bio-hazardous material in the lab environment.
Training
All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.
Other
This position requires some evenings, weekends and/or Holidays.
Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification.
This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
Top Skills
What We Do
Caris Life Sciences was founded in 2008 with a simple but powerful purpose – to help improve the lives of as many people as possible. With transformative technologies informed by massive amounts of big data, we are revolutionizing healthcare to provide physicians and patients with the highest quality information about their disease – from detecting it early and determining how best to treat it, to developing the next wave of novel therapies.
