Principal Quality Engineer - Medical Devices

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Job Title: Principal Quality Engineer - Medical Devices

Company Name:	Cardinal Health
Location:	Deland, FL
Position Type:	Full Time
Post Date:	02/10/2026
Expire Date:	03/17/2026
Job Categories:	Engineering, Quality Control, Medical

Job Description

Principal Quality Engineer - Medical Devices

Job Summary

We are seeking a dedicated and experienced Principal Quality Engineer to drive and maintain the highest standards of product quality and regulatory compliance within our medical device manufacturing operations. This role is critical for ensuring adherence to FDA regulations and ISO standards, encompassing responsibilities from design control and supplier management to advanced statistical analysis and quality auditing. The ideal candidate will leverage their expertise to proactively identify and mitigate quality risks, contribute to continuous improvement, and uphold our commitment to excellence in a highly regulated environment.

Responsibilities

Perform and support internal quality audits to ensure compliance with regulatory requirements and company standards.
Manage and oversee quality aspects of contract manufacturers and other suppliers
Analyze customer complaints and conduct appropriate investigation to increase customer satisfaction
Utilize statistical knowledge, including sampling plans, control charts, Design of Experiments (DOE), and ANOVA, for process monitoring, improvement, and problem-solving.
Conduct data mining, trend analysis, and present findings to identify areas for quality improvement and risk mitigation.
Ensure adherence to GMP (21 CFR 820) and ISO 13485 quality system requirements throughout all quality engineering activities.
Develop and maintain excellent technical documentation, including support for CE marking activities.
Collaborate effectively with cross-functional teams, demonstrating excellent interpersonal skills, self-motivation, and a proactive approach to quality assurance.

Qualifications

Bachelor's degree in engineering preferred
Preferred certifications: ASQ CQE, CMQ/OE, CQA/CBA.
4+ years of experience preferred
Prior medical device manufacturing experience is required
GMP (21CFR820) and ISO 13485 knowledge and experience
Ability to perform internal quality audits
Prior experience in supplier management/contract manufacturing preferred
Knowledge of Design control in a FDA regulated industry
Statistical knowledge including sampling plans, control charts, DOE, ANOVA etc.
Experience in data mining, trend analysis and presentation preferred
Excellent technical writing skills with CE marking knowledge preferred.
Excellent interpersonal skills, self-starter and self-motivated

Anticipated salary range:$70,400 - $100,500

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:3/10/26 *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.

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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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Contact Information

Company Name:

Cardinal Health

Website:

https://jobs.cardinalhealth.com/search/jobdetails/principal-quality-engineer---medical-devices/1aa15ea3-2a72-4302-a27a-ddefe9a085eb?utm_medium=job_board&utm_source=hbcu&utm_campaign=hbcu

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