Ingeniero de Calidad Sr.

Location: Mexico-Tijuana 9 Sur

Time Type: Full time

Job Description

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.

Job Summary

• Responsible for the validate and transfer new product Compliance and Quality Assurance of the Quality System. Supervise quality trend activities to ensure that the appropriate statistical elements are evaluated in accordance with the requirements of the Quality System

Responsibilities

• Responsible for the validate and transfer new product Compliance and Quality Assurance of the Quality System.

• Supervise quality trend activities to ensure that the appropriate statistical elements are evaluated in accordance with the requirements of the Quality System
•  Direct Quality responsibilities: for quality internal and external audits, CAPA site system and document change control.
• Support as an auditor for suppliers and manufacturers to comply with QSR / ISO and corporate procedures.
• Manage and develop people under his/her supervision. Support the investigation activities of customer complaints.
• Approve the quality audit program in accordance with CFR 820 / ISO 13485, and other applicable regulations.
• Keep the internal audit procedure updated in accordance with the requirements of CFR 820, ISO 13485, and other applicable regulations.

• 
  Qualifications

• 4-6 years of experience in medical device manufacturing or similar
• Solid knowledge of Validation principles and best practices
• English: Intermediate Advance
• ISO13485 knowledge
• BA, BS or equivalent experience in related field

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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