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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.

Job Summary

The Senior Design Quality Engineer is responsible for leading and managing quality assurance of medical device products and processes. This position will lead quality and compliance activities for Cardinal Health which includes diverse medical devices. Design Quality Engineers ensure that product quality and regulatory compliance goals are met for new product development projects and released products.

Responsibilities

• Participate in the creation or modification of activities such as Design Input, Design Output, Design Verification, Design Validation, Risk Management files, Critical to quality Matrix, Mechanical Drawing, Bill of Materials, Complaint Analysis, Review of Clinical Documents, Label Reviews, Standard Gap Assessment, Biocompatibility Risk Assessment, Risk Management File Review.
• Perform activities related to Risk Management Plan, Hazard Identification Worksheet, Risk Analysis Chart, and Risk Management Report
• Ensure that products compliance to ISO 13485 and 21 CFR 820 Quality system regulations by providing support for interpretation of regulations, performing gap analysis and lead activities to implement improvements.
• Work closely with Research and development, Regulatory, Medical Affairs, Supplier, Audit, CAPA and Program Management team.
• Analyze quality audit findings and recommends modifications in products or standards. Proactively identifies opportunities for system compliance improvement and leads activities to implement improvement.
• Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
• Involve in continuous improvement activities.
• Identifies and implements data analysis, system conformance and ensure finished goods meet standards and specifications, implement and drive changes where needed.
• May contribute to the development of policies and procedures
• Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives
• Complete task independently after receiving general guidance on new projects
• May require to travel to design site or to manufacturing site as needed (approximately 5% annually)
• Perform other duties as assigned.

Qualifications

• Bachelors in engineer, preferred or equivalent experience in related field preferred
• 2-3 years of experience preferred
• Good written and oral communication skills
• Strong analytical and problem-solving skills.
• Working knowledge of Design Control and Risk Management in an FDA regulated industry preferred
• Knowledge in test methods and standards for qualification of products and equipment preferred
• Knowledge in product risk management to the requirements of ISO 14971 preferred
• Understanding of federal, state, local and industry standards, guidelines, and regulations (i.e., AAMI, ANSI, GMP,21CFR820 and ISO 13485) preferred
• ASQ Certified Quality Engineer preferred

Anticipated salary range: $66,500 to $95,000

Bonus eligible: No

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

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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We are a team of nearly 48,000 mission-driven partners striving each day to advance healthcare and improve lives. We are Essential to care.

Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for health care facilities

We are a crucial link between the clinical and operational sides of care, working with more than 4,500 sourcing and manufacturing partners to deliver end-to-end solutions and data-driven insights that advance healthcare and improve lives every day. With deep partnerships, diverse perspectives and innovative digital solutions, we build connections across the continuum of care.

With 50 years of experience, approximately 44,000 employees and operations in more than 30 countries, Cardinal Health seizes the opportunity to address healthcare’s most complicated challenges — now, and in the future.

On Thursday, Jan. 7, 2021, we celebrated the day our founder, Bob Walter, had the vision to start a business that became known as Cardinal Health.

One of the most important ways we celebrated was by giving back to the communities where we live and work. 2021 was a "Year of Service” for all Cardinal Health employees around the world.

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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.