What are the responsibilities and job description for the Quality Engineer position at Katalyst Healthcares & Life Sciences?
Summary :
The Quality Engineer plays a key role in proactively planning, deploying, and sustaining quality into products and processes using Caterpillar's Advanced Product Quality Planning (APQP) and New Product Introduction (NPI) frameworks. This position is accountable for quality leadership across new product and new capital programs, from concept through production validation and launch. The role emphasizes prevention-based quality fundamentals, front-end risk identification, and cross-functional execution to ensure robust, capable processes and successful launches.
Roles & Responsibilities :
The Quality Engineer plays a key role in proactively planning, deploying, and sustaining quality into products and processes using Caterpillar's Advanced Product Quality Planning (APQP) and New Product Introduction (NPI) frameworks. This position is accountable for quality leadership across new product and new capital programs, from concept through production validation and launch. The role emphasizes prevention-based quality fundamentals, front-end risk identification, and cross-functional execution to ensure robust, capable processes and successful launches.
Roles & Responsibilities :
- Lead APQP execution for NPI and NCI programs, ensuring early identification of validation plans, audit strategies, and project readiness reviews.
- Support PFMEA development, ensuring risks are identified early and mitigated appropriately.
- Develop, review, and maintain Control Plans aligned to PFMEA risk, process capability, and customer requirements.
- Serve as quality lead on NPI and capital programs, supporting design readiness, manufacturability, inspection strategy, and error-proofing.
- Lead process validation activities including capability analysis, production trials, and run-at-rate evaluations.
- Partner with manufacturing, operations, and engineering to ensure internal process readiness.
- Support early production launches by monitoring quality indicators, addressing emerging risks, and driving preventive actions.
- Lead structured problem-solving when required, while ensuring lessons learned are fed back into APQP documentation.
- Identify and support quality metrics focused on risk prevention and launch robustness.
- Provide APQP and quality fundamentals training to cross-functional teams.
- Bachelor's degree in Engineering, Manufacturing, or a related technical discipline.
- 3 years of progressive experience in Quality, Manufacturing, or Product Engineering.
- Demonstrated experience with APQP, including PFMEAs and Control Plans.
- Strong cross-functional indirect leadership.
- Strong communicator - able to influence and engage with individuals at all levels of the business to build trusted partnerships.
- Proven analytical and structured problem-solving capability.
- Experience supporting New Product Introduction (NPI) and/or New Capital Introduction (NCI).
- Quality certifications such as ASQ-CQE or Six Sigma Green/Black Belt.
- Experience with process capability analysis and error-proofing methods.
- Familiarity with Caterpillar manufacturing and quality systems (AQE, MESA, deviation management).