Gerente de Calidad

What QRA Management contributes to Cardinal Health

QRA Management is responsible for strategic oversight and leadership direction over multiple job families or areas of expertise within the QRA function.

Accountabilities

• Manage day-to-day Quality Control functions including

  • Quality Control: scheduling of inspections, line support and testing

  • Document Control: management of all pertinent data bases

  • Quality related audits and certifications

• Partners with site Director and managers to Recruit, hire, develop/supervise and train Quality Control and Document Control personnel including performance reviews in accordance with Departmental and Corporate practices

• Define, communicate and enforce quality policies focused on CAH and external compliance and regulatory

• Coordinate QRA functions and activities between departments. Determine responsibilities and procedures for ensuring that this function is performed effectively, and objectives are achieved

• Participate and assist in the formulation and establishment of organizational policies and quality procedures for the Quality Control department

• Participate and leads systems improvements project teams as required

• Meet with production management on regular basis and support goals outlined in the company s operating plan

• Budgeting, planning and resource evaluation in line with Zero Base Management initiatives

• Develop strategies to implement Quality system regulations and continuously improve Quality processes

• Promotes communication, development and process improvement

• Solid leadership skills with the ability to influence other to ensure adherence to quality excellence

Qualifications (minimum requirements)

• Bachelor’s in engineering, Life Sciences or similar

• 5+ years’ quality experience in related field within medical industry environment

• 3+ years management experience - solid leadership and influential partnership skill

• Advance fluency in English / Spanish

• Strong product manufacturing technical background as well as knowledge of Medical Device Quality System regulations

• Experience in product manufacturing transfers, facility/line startup, etc.

• Experience in product design and transfer processes USA to MEX or similar

• Experience managing external Regulatory Agency compliance audits (FDA, ISO13485) highly preferred

• Kaizen, Six Sigma Certification highly preferred

• Ability to travel up to 20%

What is expected of you and others at this level

• Manages department operations and supervises professional employees, frontline supervisors and/or business support staff

• Participates in the development of policies and procedures to achieve specific goals

• Ensures employees operate within guidelines

What is expected of you and others at this level

• Manages department operations and supervises professional employees, frontline supervisors and/or business support staff

• Participates in the development of policies and procedures to achieve specific goals

• Ensures employees operate within guidelines

• Decisions have a short term impact on work processes, outcomes, and customers

• Interacts with subordinates, peer customers and suppliers at various management levels may interact with senior management

• Interactions normally involves resolution of issues related to operations and/or projects

• Gains consensus from various parties involved

Relocation support is available within Mexico.

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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