Principal Quality Engineer - Medical Devices
About The Position
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.
Requirements
- Bachelor's degree in engineering preferred
- 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
Nice To Haves
- Preferred certifications: ASQ CQE, CMQ/OE, CQA/CBA.
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.
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
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What This Job Offers
Job Type
Full-time
Career Level
Principal
