Quality Engineer 2
In this role, you have the opportunity to
Provide engineering support 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.
You are responsible for
Interfacing well with others, especially Manufacturing Engineering.
Ensure Risk Management is effective utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, HHAs, etc. Familiarity with ISO 14971, Risk Management for medical devices.
Develop, implement and monitor quality metrics. Communicate status and progress.
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.
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.
Support computer system validations for manufacturing and test equipment.
Lead and support test method validations plans/protocols and reports.
Experienced with statistical techniques, including design of experiments (DOE); able to analyze results.
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.
You are a part of
Describe in two to three lines the place of the role in the organization and the team culture.
To succeed in this role, you should have the following skills and experience
2+ years as an Engineer in the related field
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 preferred
Statistical analysis (Minitab), JMP software preferred
Proficient in the use of various measuring tools and troubleshooting equipment
Experienced in Medical Device Design control process is preferred.
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
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