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Manager, Quality Regulatory Affairs

Expired Job

Cardinal Health Jacksonville , TX 75766

Posted 4 months ago

What QRA Management contributes to Cardinal Health

A QRA Manager is an influential leader who has responsibility for strategic oversight and direction of the manufacturing site quality system, quality team, and quality culture and site commitment to customers and patients.

Accountabilities

The Quality Manager is responsible for implementation and administration of quality management programs for production operations at the Jacksonville, TX site. As a key member of the Jacksonville Site Leadership team the Quality Manager works closely with the Operations Management Group. The team has responsibilities to insure our quality standards are met. The Operations and Quality team work closely to make key product, service and quality decisions, which may have significant impact on the business.

The Leader in this role must be comfortable working with all layers in the business, from operations employees through senior leadership.

The Quality Manager is directly responsible for quality and regulatory compliance, and site quality and operations metrics. The responsible leader will insure the site works to continually improve quality performance, through an integrated approach. The Quality Manager will be part of the larger Cardinal Health network of Quality Managers and readily participate with peers to share best practices, and lessons learned.

The Quality Manager is the Management Representative for the Cardinal Health Jacksonville facility and is therefore responsible for ensuring that the Quality System requirements are continuously met and maintained, that Cardinal Health wordmarked products bearing the CE mark meet/satisfy all the requirements of the Medical Device Directive/Regulation, ISO 13485:2016, CMDR, and that the product meets all of the requirements of FDA CFR 820.

The key values of a leader in the quality organization of Cardinal Health include:

Best Version of You

  • Adopt the Right Mindset
  • When challenges arise, focuses on what s/he can solve. Maintains composure; is not defensive or irritated when challenged with adversity
  • Lean Into Change
  • Open and adaptable to change. Effectively adjusts to changes and deals effectively with uncertainties. Actively leads through changes they see coming or wants to lead with energy, and confidence.
  • Embrace the Difficult
  • Generates valuable ideas and effective solutions to difficult problems; action oriented, works hard to execute challenging tasks.

Excellence with Integrity

  • Understand the Business
  • Understands the big picture and impact of the work we do. Knows how the business works, and how to apply the regulatory and compliance rules.
  • Anticipate and Solve Problems
  • Displays self-awareness and situational awareness, effectively anticipates future consequences and trends, comes with options and solutions for how to address risks and problems. Settles conflicts equitably in a professional manner, listens to opposing opinion, compromise.
  • Do What is Right Even When it is Hard
  • Protects the patients, customers, company, employees. Develops a culture of integrity and compliance, does what is right - every time.

Power of the Team

  • Choose 'We' over Me
  • Has a one team attitude - we get the work done together, find solutions together. Has a well-rounded team of individuals with unique skills. Humble, collaborative.
  • Care, Listen, Engage
  • Treats others with consideration, directly and indirectly. Listens to understand, asks how they can help, shares credit for work, and accepts responsibility for their work and work of their team.
  • Invest in Relationships
  • Builds strong relationships, in and out of the site working to build trust. Gets to know on his/her team and site team. Builds productive relationships, has positive intent, coaches, mentors and develops others

ESSENTIAL FUNCTIONS:

The major activities of the Quality Manager are:

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

  • Lead, coach and develop all personnel within the Quality team to continually improve site quality performance, and manufacturing efficiency.

  • Validation of product designs, manufacturing processes, equipment, and procedures required for the production and delivery of finished product. This will include active membership/participation in the Jacksonville Technical Council.

  • Establish systems and documentation required for the implementation and maintenance of a 21 CFR Part 820 total quality system and compliance to applicable International standards, such as ISO 13485 MDD/MDR, CMDR, etc.

  • Coordinate effective management reviews, including gap analyses

  • Coordinate training of the Quality System to Executive Management

  • Support the maintenance of the associated product Technical Files

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

  • 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.

Qualifications

Knowledge:

  • This position requires a bachelor's degree, preferably in a technical field relating to engineering or science.

  • A minimum of five years with eight years experience preferred 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 13485:20016, MDSAP, MDD/MDR, QSR's, and CMDR) is required.

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

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.

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

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.


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Manager, Quality Regulatory Affairs

Expired Job

Cardinal Health