In this role, you have the opportunity to
As a Senior Quality Engineer, you will have the opportunity to provide engineering leadership on a daily basis by developing, establishing and maintaining quality engineering methodologies, systems, and practices which meet world class standards. Among other tasks you will investigate non-conforming events and product failures to drive product/process improvements with the objective of compliance safety and high customer satisfaction. Serve as a multi-functional team leader for quality improvement teams assuring commitments and objectives are achieved with positive results.
You are responsible for
- Must be able to interface well with others, especially Manufacturing Engineering and R&D Engineering.
- Provide coordination and guidance to cross functional teams to ensure product quality objectives are met.
- Ensure Risk Management is effective utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, HHAs, etc. Experience with ISO 14971, Risk Management for medical devices.
- Develop, implement and monitor quality metrics. Communicate status and progress.
- Assure compliance with Philips IGT procedures and applicable standards/ regulations (i.e. QSR, ISO, GMP, etc)
- Develops systems for monitoring manufacturing quality. Recommends and assists, as necessary, in the implementation of corrective/preventative actions.
- Lead problem-solving teams through root cause investigations and failure analysis to implementation and final verification.
- Lead and support Health Hazard Analysis (HHAs) to ensure risk assessment and root cause analysis are consistent across products and systems.
- Lead and support complaint management activities.
- Develop validation strategies so that all appropriate requirements are being met from planning, protocol definition, leading execution of protocol, analyzing and reporting results and defining procedures and training requirements, completing report and gaining approval to close.
- Participate in the development and results analysis of validation plans (IQ/OQ/PQ) and test protocols to qualify and validate existing and new product designs and processes. Includes the use of various statistical techniques and quality tools.
- Experienced with statistical techniques, including design of experiments (DOE); able to analyze results.
- Lead and support test method validations plans/protocols and reports.
- Support computer system validations for manufacturing and test equipment.
- Determines and recommends sampling plans, equipment requirements, measurement techniques and training requirements that will assure specific quality levels.
- Lead the non-conforming material process and participate in or lead the Materials Review Board.
- Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
- Experienced in inspection and testing techniques; must be able to read and interpret blueprints.
- Experienced in Medical Device Design controls. Support defining Design inputs, outputs, specifications, acceptable quality levels and write/review Design verification plans/protocols and reports.
- New product development experience is preferred.
- Knowledge of Medical Device QSR and ISO 13485.
- May supervise a junior Engineer, technician or intern, as necessary.
To succeed in this role, you should have the following skills and experience
- Minimum of 8 years as an Engineer in the related field or a combination of equivalent education and relevant experience.
- BS in Mechanical Engineering, Biomedical Engineering, Process Engineering, Analytical Chemistry, or related technical discipline, preferred.
- Solid experience in Risk Management for medical devices ISO 14971desired
- Application and leading problem-solving, root cause analysis and related Corrective and Preventive Action
- Regulated industry experience required
- Statistical analysis (Minitab), JMP software required
- Proficient in the use of various measuring tools and troubleshooting equipment