Principal Quality Engineer, Validation

Anticipated salary range: $79,700 - $119,490

Bonus eligible: No

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Application window anticipated to close: 04/20/2025 *if interested in opportunity, please submit application as soon as possible.

The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

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

Responsibilities

• Required: Work with radiation and in radiation-controlled spaces
• Conducts & develops validation and qualification protocols, projects and studies supporting manufacturing facility start-up and operation. Validation documentation to ensure products are manufactured in accordance with cGMP, pharmaceutical regulatory agencies, manufacturer, and Cardinal Health specifications/requirements.
• Maintains close contact with various functions to assure effective communication on challenges and opportunities related to validation.
• Provides technical support as needed.
• Develops policies, programs, SOPs, and Quality standards to meet current industry, corporate Quality, and external Regulatory requirements regarding validation.
• Supports the facility in internal and external regulatory inspections.
• Works directly with management, contract customers, and/or contract engineers.
• Maintain effectiveness of the Quality System components relevant to this position.
• Works autonomously with minimal supervision.
• Develops, maintains, and enforces Cardinal Health compliance standards.
• Learns and carries out laboratory procedures or operate equipment as needed to perform qualification testing.
• Performs other job duties as assigned.

Qualifications

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Chemistry, Metrology or related science field, or equivalent work experience preferred
• 3 or more years of relevant work experience as a Validation Engineer, Quality Assurance Engineering, or Quality Validation Consultant working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device).   
• Experience with equipment qualification, software validation, test method validation, and/or process validation.  
• Validation and Technology Transfer process and experience with writing procedures/ reports and execution of laboratory test. 
• Must be detail oriented, organized, able to multi-task, a self-starter, and self-motivated.  
• Must be proficient in Microsoft Word and Microsoft Excel and possess strong technical writing skills.  
• Preferred: Experience working with radiopharmaceuticals
• Preferred: Certified Quality or Reliability Engineer
• Preferred: Authorized User (NRC)

What is expected of you and others at this level

• Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects.
• May contribute to the development of policies and procedures.
• Works on complex projects of large scope
• Develops technical solutions to a wide range of difficult problems.
• Solutions are innovative and consistent with organization objectives.
• Completes work; independently receives general guidance on new projects.
• Work reviewed for purpose of meeting objectives.
• May act as a mentor to less experienced colleagues

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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