Regulatory Compliance Engineer

What Quality Compliance contributes to Cardinal Health

The regulatory compliance engineer is responsible for collection, analysis and review of defined metrics to measure and improve safety and effectiveness of Cardinal Health products, customer satisfaction, regulatory compliance and suitability and effectiveness of the Cardinal Health quality management system.

The regulatory compliance engineer is also responsible for ensuring a permanent state of compliance with corporate and applicable regulations.

Qualifications

• 2-4 years of experience, preferred

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

• Must be able to speak, read and write in the English language.  English level desirable B2 (80%-89%)

• Requires excellent computer skills, proficiency in MS Office.

• Minitab and Power BI preferred.

What is expected of you and others at this level

• Assure compliance with regulations as ISO13485, MDSAP and others applicable regulations based on product requirements.

• Collect, analyze and review defined metrics, described in Cardinal Health Quality Management System.

• Perform robust investigations for quality issues acting as CAPA coordinator.

• Perform NCRs evaluations as required for QA systems events.

• Perform customer complaint investigations. Determine root cause or potential cause and corrective/ preventive actions for customer complaints.

• Execute activities and responsibilities according to applicable procedures for Complaints, Audits, NCRs and CAPA.

• Review and update documents within their areas of responsibility in order to be in compliance with Corporate and Regulatory Requirements.

• Develop and/or lead continuous improvements initiatives of the Quality System.

• Coordinate logistics and preparation of Management Review meetings.

• Develop continues improvements initiatives of the Quality System of Costa Rica Site. Participate and support Quality Systems activities for improvement, projects, transfers, new processes implementations, etc.

• Perform other related duties as required.

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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