Ingeniero Sr de Calidad

What Quality Engineering contributes to Cardinal Health
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Engineering manages product and service quality planning, evaluation and control. This job family works cross-functionally in the development and implementation of prevention-based methodologies used in designing, manufacturing, testing, and correction of products and services. The Senior Engineer Quality Engineer Molding leads quality assurance processes at the assigned facility.

Responsibilities

• Provide Quality Engineering leadership to Manufacturing Operations and ensure compliance to regulations, procedures, and standards applicable to Cardinal Health.

• Lead and participate in continuous quality improvement activities.

• Responds to complaints and non-compliance and signs off on deviations, validation, and other design verification protocols.

• Ensures that the on-site lab is testing and escalating issues that arise.

• Conducts trending analysis with non-conformance compliance and develops month-end reports and management reviews.

• Develops correctional and preventative actions for quality related processes.

• Serves as an internal auditor and leads external regulatory auditors throughout the facility.

• Provides leadership and facilitates problem solving, resource utilization, career guidance, coaching, and mentoring of team members.

• Provides experience in the manufacturing operations of medical devices, including verification and validation of processes and test methods.

• Coordinates with multifunctional team root cause investigations using analytical and problem-solving skills: root cause analysis.

• Follow the safety rules to avoid accidents, occupational diseases, and environmental contingencies within the plant.

• Participate and elaborate  projects to reduce costs.

• Responsible of the validation, maintenance and establishment of test methods and measurement equipment

• Mentors junior employees.

Qualifications

• 3+ years of QA experience in Molding

• Prior medical device manufacturing experience

• Bachelor's degree in related field, or equivalent work experience,

• English: Advance

• Experience in Molding and sustainability

• Understanding of ISO13485 and FDA regulations

• Solid analytical skills

What is expected of you and others at this level

• Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks

• Works on projects of moderate scope and complexity

• Identifies possible solutions to a variety of technical problems and takes action to resolve

• Applies judgment within defined parameters

• Receives general guidance and may receive more detailed instruction on new projects

• Work reviewed for sound reasoning and accuracy

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

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