Scope of Responsibilities

Quality System development, review, and maintenance.  Maintain Quality Manual.

Conducting Site Quality Management Reviews and reporting of KPI metrics, and escalations to corporate Management Reviews and site management.

Provide strategic oversight, leadership and direction to technical and administrative direct reports within the Quality operations and regulatory compliance function.

Manage, develop, train and guide direct reports, quality staff, and site personnel to achieve site quality goals and maintain regulatory compliance. 

Develop, monitor and control QA budget for the Costa Rica Facility.

Transferring product designs to manufacturing (Design Transfers) and Mfg. site-to-site transfers.

Serves as a liaison with Design Engineering/R&D engineering, Medical Safety, Supplier and variety of services providing functions on manufacturing and product matters.

Develop strategies to continuously improve mfg. and product quality and to simplify and optimize processes to increase efficiency and enhance productivity

Provide guidance to all departments within the facility to ensure compliance with corporate procedure and directives as well as maintaining compliance with QSR and ISO standards and requirements. Demonstrate commitment to quality by not sacrificing quality for cost or speed of delivery.

Management Representative for the Costa Rica site and point person/host during Corporate, internal, and external audits.

Provide responses to FDA, ISO, Internal, External, Corporate, and customer audit findings as required. Initiate any necessary corrective and preventive actions.

Stay current with and communicate FDA enforcements and requirements.

Managing site supplier quality function and interact with Materials group regarding Supplier corrective and preventive actions and non-conformances.

Communicate with COSTA RICA management staff regarding customer complaints, corrective and preventive actions, MDRs, product holds or field actions.

Determine root cause for key system deficiencies which drive compliance and continuous improvement.

Manage facility validation activities. Deviation review and approval.

Manage facility quality system and regulatory compliance function, including document control, internal auditing, and customer complaint handling, as well as maintain record storage and retention integrity.

Material Review Board (MRB) review and approval.

Support COSTA RICA Strategic Plan as identified by the Plant Director.

Use consumer/customer feedback to shape future directions.

Foster group decision making and teamwork through open and honest communications, constructive feedback, delegating authority, positive performance reinforcement, and healthy relationships based on mutual trust, respect and lead by example.

Other activities as required by Corporate Quality Assurance directives or Costa Rica's Plant Director.

Qualifications

Education

Bachelor’s degree in engineering or science field required, in Biomedical engineering, mechanical engineering, chemical engineering, electromechanical engineering or similar

Experience

8+ years of leadership experience in the quality manufacturing or similar

Solid medical manufacturing industry experience

Experience leading over 150+ professional, technical, and associate employees

Communication

Effective communication and proficient in English and Spanish(verbal and written)

Other Qualifications

Demonstrated knowledge in FDA regulations and ISO 13485 std requirements, and MDSAP certification

Demonstrated knowledge of process for risk management of medical devices and ISO standard 14971

ASQ management and/or quality engineering certification (ASQ CMQ/OE, ASQ CQE), preferred

Demonstrated project management skills and experience

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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