Quality Engineer

• Career development with an international company where you can grow the career you dream of.

• Health Insurance (starting on Day 1 of employment), Savings Plan (401K) with company match, Life insurance for you and your spouse/children, Short Term Disability, Long Term Disability, Education Assistance, Employee Assistance Program, Vacation, Sick, Personal Days.

• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

• Identifies manufacturing process defects (scrap, nonconforming material, customer complaints), dispositions non-conforming material, leads identification of primary root causes for basic investigations, identifies appropriate corrective and preventive actions.

• Supports line support team (QC Supervisor, Mfg Supervisor, Quality Engineer and Operations) to perform line situation triage and determine if non-conformance is present, determine initial bracketing and containment, and initiate exception management process.

• Owns basic to moderate exception / CAPA activities without oversight.

• May be responsible for working with process owner to bound product stops and document release criteria.

• Can perform lot to lot yield and rework evaluation.

• May be responsible for reporting of quality metrics.

• Understands product quality plans, documents, and quality systems.

• Develops product quality plans, documents and systems by providing input to product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other product development team members.

• May be responsible for owning and maintaining product risk analyses and FMEAs.

• Monitors process by using process monitoring tools and Infinity QS to reduce process variation.

• Becomes familiar with Product/Process improvement efforts by understanding current quality metric data and learning the various analysis methods used to enhance sustaining product design and new product development.

• Understands Quality Tools & Training Materials and helps others in gaining knowledge of prevalent tools used and available training materials.

• Can lead Product/Process improvement efforts (e.g). scrap, nonconforming product, customer complains) by systematically gathering quality metric data and by using appropriate analysis methods to enhance sustaining product design.

• Runs routine problem-solving investigation without oversight and use of six Sigma tools.

• Implements minor and major changes through change management system and provides quality engineering impact assessment for changes implemented by other functional areas.

• May write protocols and reports with management oversight to support engineering studies and validations.

• B.S. in engineering discipline

• 2 years of experience in Quality and/or Compliance, preferably in medical device industry

• Knowledge of applicable US non-US applicable regulations.

• Knowledge and proficiency in the application and principles of Quality Engineering.

• Ability to effectively communicate cross-functionally to assist with resolving Quality issues.

• Excellent written, verbal and interpersonal communication skills in both English and Spanish.

• Ability to interact effectively with all levels of employees.

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