Principal Quality Engineer

Quality Engineering

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-functional in the development and implementation of prevention-based methodologies used in designing, manufacturing, testing, and correction of products and services.

This is a hybrid (3+day in the office) position. The candidate needs to be in either Hazelwood, MO or Mansfield, MA.

Responsibilities

• Responsible for participating in product design and development.
• Conduct data and risk assessments for various product lines.
• Apply FDA QMS/QSR to provide regulatory support (strategy) for new product development, change assessments, design verification and validation, design control.
• Revise SOP documentation and create and approve change orders.
• Work cross-functional with engineering, regulatory and design to introduce new line extensions and new products as well as day-to-day operations to support manufacturing and continuous process improvements.
• Provide oversight and participate in CAPAs, NCR, complaints and audits.

Qualifications

• Bachelors degree in engineering or relevant work experience, preferred.
• 4-8 years of experience in related field, preferred.
• Understanding of federal, state, local and industry standards, guidelines, and regulations (i.e., AAMI, ANSI, GMP, 21CFR820, 14971 and ISO 13485), preferred.
• Excellent attention to details and organizational skills.
• Excellent interpersonal skills and ability to collaborate cross-functional with Engineering, Manufacturing, Supplier Quality, Compliance, Packaging, Labeling, Marketing, etc.
• Strong analytical, problem-solving, and technical writing skills.
• Proficient with Microsoft office, Minitab or related software and applications, preferred.
• Knowledge of Internal and External Audit Activities, preferred.
• Knowledge and confidence lead to the identification, investigation, and resolution of quality issues by conducting thorough root cause analysis and implementing effective Corrective and Preventive actions (CAPA), preferred.
• Knowledge in supplier quality management, contract manufacturing processes and private brand development to ensure product excellence and strategic alignment, preferred.
• ASQ, BSI, IRCA or related Certifications are a preferred.

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.

Anticipated salary range: $80,900 - $121,275

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: 10/10/2025 *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 candidates geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

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.