What Quality Engineering 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 Engineering manages product and service quality planning, evaluation and control. This job family works cross-functionally in the development and implementation of prevention-based methodologies used in designing, manufacturing, testing, and correction of products and services.

Accountabilities

• This position will work as a member of cross-functional project teams engaged in ongoing Product Life Cycle technical support.
• Will serve as a quality representative on project teams and will work closely with R&D, Operations, Regulatory Affairs, Marketing and Distribution.
• May be expected to initiate quality initiative projects, become thoroughly knowledgeable with all aspects of Sustaining and/or New Product Development projects, and assume personal responsibility for the successful completion of all tasks within the realm of Quality Engineering responsibilities.
• Participate in the creation and maintain risk management and usability documentation such as, Hazard Analysis, Design Failure Mode and Effects Analysis (DFMEA), Task Analysis and Fault Tree Analysis (FTA) incorporating both IEC 62304 and Cybersecurity principles.
• Identify risk-based requirements within the Quality System (21 CFR 820/ ISO13485) for the Medical Device Software process, IEC 62304.
• Ensures that principals of Design Control are applied to Product and Process Changes and New Product Development.
• Creates reviews and approves Risk Management Files documents such as: Risk Management Report, Hazard Analysis, Risk Benefit Analysis and FMEA’s.
• Leadership in continuous improvement projects.
• Creates, reviews, and approves Design Specifications, Design Verification Protocols and reports, Process and Product Validations, Software Validation documents and Test Method Validations.
• Creates, reviews, and improves Quality System Documents (CAPA, Audits, Risk Management, Design Control.
• Drives Reliability planning and Quality Planning for New Product Development.
• Other duties as assigned .

Qualifications

• Bachelors Degree in related field preferred or equivalent work experience.
• 8-12 years experience in related field preferred
• Experience in Design Controls for Electromechanical Medical Devices and Disposables including design transfer to manufacturing preferred
• Risk Management and Reliability Engineering experience preferred
• Ability to understand Medical Devices Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency.
• Medical Device Software process, IEC 62304. ISO 14971 & 13485
• Expertise in Design Verification, Design Validation Process, Test Method and Software Validation for Medical Devices.
• Ability to participate and provide leadership on teams and maintain positive work environment with those teams.
• Understands team functions, leadership technique, time management, project management methodologies and able to balance multiple task assignments.
• Excellent communication skills (verbal, written, and presentation).
• Understands how to present information dependent upon the level of the audience.

What is expected of you and others at this level

• Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects
• Participates in the development of policies and procedures to achieve specific goals
• Recommends new practices, processes, metrics, or models
• Works on or may lead complex projects of large scope
• Projects may have significant and long-term impact
• Provides solutions which may set precedent
• Independently determines method for completion of new projects
• Receives guidance on overall project objectives
• Acts as a mentor to less experienced colleagues

Anticipated salary range: $106,300-$151,800

Bonus eligible: Yes

Benefits: Health insurance, 401k Contributions, Paid Time Off, Vacation, STD/LTD

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.