Scope of Responsibilities
Product Lifecycle Quality: Provide quality oversight throughout the product lifecycle, from design control and development through manufacturing, inspection/testing, and post-market surveillance.
Quality Management System (QMS) Oversight: Develop, implement, manage, and continuously improve the QMS to ensure compliance with global regulations and standards, including FDA Quality System Regulation (21 CFR Part 820), ISO 13485:2016, EU MDR, and MDSAP.
Regulatory Compliance and Audits: Serve as the primary representative during regulatory inspections and third-party audits (e.g., FDA, notified bodies). Ensure timely and effective responses to audit findings and the implementation of corrective actions.
Corrective and Preventive Actions (CAPA): Oversee the entire CAPA lifecycle, including investigation, root cause analysis, documentation, and verification of effectiveness, to address non-conformances and customer complaints.
Risk Management: Lead and implement risk management strategies and activities, including hazard analysis and FMEAs (Failure Modes and Effects Analysis), in accordance with standards like ISO 14971.
Supplier Quality Management: Manage the supplier quality program, including conducting supplier evaluations/audits, establishing quality agreements, and ensuring the quality of incoming materials and components.
Continuous Improvement: Drive process optimization and continuous improvement initiatives using methodologies such as Lean and Six Sigma to enhance efficiency and product quality.
Leadership and Mentoring: Supervise, train, and mentor the quality assurance and quality control teams, fostering a strong quality culture and professional development.
Documentation Control: Ensure robust documentation practices, including the review and approval of device history records (DHRs), manufacturing batch records, standard operating procedures (SOPs), and work instructions.
Qualifications (minimum requirements)
Bachelor's degree in engineering, , life science, or a related field.
10+ years of progressive experience in quality assurance/quality management within an FDA-regulated medical device.
English: advance/fluent
Experience transferring product designs to manufacturing (Design Transfers) and Mfg. site to site transfers
Experience developing strategies to continuously improve mfg. and product quality and to simplify and optimize processes to increase efficiencies and enhance productivity
Experience working in large manufacturing medical device plants (+2,500 employees)
Communication: Advance/Fluent proficiency in English and Spanish with the ability to present clear and concise ideas across the organization and diverse business groups.
Leadership: 10+ years of leadership experience in the medical industry. Proven experience leading over 100+ professional, technical, and associate employees. Fosters development and promotes a safe environment.
Certifications: In-depth knowledge and hands-on experience applying medical device regulations (e.g., FDA 21 CFR Part 820, ISO 13485, EU MDR, MDSAP).
Skills: Strong analytical, problem-solving, and communication skills, with the ability to lead cross-functional teams and influence stakeholders at all organizational levels.
Systems: Solid computer skills, proficiency in MS Office suite and Minitab preferred.
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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