What Quality Management 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 Management provides strategic oversight, leadership, and direction within the Quality function.

In order to Protect & Grow Our Core business, we need a dedicated strong site QRA lead working with our AeroMed Operations team to ensure we partner in our commitment to product quality, safety, and integrity for our global customers.

Responsibilities

• Act as Management Representative for the Cardinal Health AeroMed facility.

• Manage and develop all personnel within the Quality function in order to maintain and improve overall efficiency of plant operations.

• Validation of product designs, manufacturing processes, equipment, and procedures required for the production and delivery of finished product.

• Establish systems and documentation required for the implementation and maintenance of a 21 CFR Part 820 quality system and compliance to applicable international standards, such as ISO 13485 Medical Device Directive, CMDR, etc.

• Coordinate effective management reviews, including gap analyses

• Coordinate training of the Quality System to Executive Management

• Provide support and resources for the administration of Project Management, Design Control, Research, Development & Engineering efforts within the facility, as needed.

• Initiate and direct corrective actions to problems relating to product or process quality, such as complaint resolution, customer interface, regulatory action.

• Provide liaison between the operations management and regulatory agencies (FDA, ISO, DOH) regarding audit findings, litigation, and complaints.

  • Support Risk Assessment techniques and methods (FMEA) in addressing design and improvement projects.

• Establish and implement quality systems that will support the key strategies for the plant with emphasis on continuous value improvements in total cost, quality, service, and innovation.

• Improve facility operations through implementations of quality management specifications, procedures, test methods, and measurement systems.

• Foster cross-functional integration of the Quality Organization with all other business unit functions by maintaining productive working relationships and promoting QA involvement.

• Manage departmental spending within the budget

• Support plant EH&S initiatives and foster safe working conditions in the department and the plant.

• Evaluate the impact of any new product or changes to existing products on regulatory applications.

• Maintain the high level of compliance and achieve annual site MDSAP, ISO13485 certifications with no critical/major findings. 

• Ensure adequate closure of corporate audit and Sidley diagnostic audits.

• Establish clear Trending & Escalation Guidelines (to ensure timely detection of signals and drive proactive actions).

• Progress all quality plans, including supplier quality, ensuring milestones are met.

• Support Site specific Quality KPI improvement goals and develop get well plans as required.

• Develop the site team improving Succession Planning and Bench Strength Skills and abilities:

• Communication, multi-task management, and leadership skills are required for effective performance in this position.

• This position will serve in a results-driven environment and requires a team-oriented individual.

• The position facilitates team-based management, developing supportive relationships with all departments, functions, and personnel in dealing with quality problems, initiatives, and corrective actions.

Essential Capabilities:

• Must be able to manage multiple areas of responsibility

Other Characteristics:

• Must be able to manage and complete other duties as assigned.

Qualifications

• Bachelor's degree in related field preferably in a technical field relating to engineering or scient, or equivalent work experience.

• A minimum of five years' experience in the following areas: Quality Management & Regulatory Affairs, medical device manufacturing, FDA (CFR 820) and ISO/EC requirements, statistical techniques, and sampling methods.

• This position prefers certification as a Six Sigma Engineer, ASQ Quality Engineer, ISO Lead Assessor or ASQ Quality Auditor.

• Knowledge of applicable standards (i.e., ISO 13485:2003, MDD, QSR's, and CMDR) is required.

• 3 years of supervisory experience preferred

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.