Quality Engineering Supervisor
hace 4 semanas
Role Overview: The Quality Engineering Supervisor will serve as a pivotal regulatory authority for functional teams, overseeing the execution of change management and validation activities for products, processes, materials, and software.
Key Responsibilities:
- Provide support and guidance from a Quality Assurance Engineering perspective for all project-related activities impacting the facility, product, and manufacturing operations, including VIPs, cost-saving initiatives, and continuous improvement efforts.
- Lead the Risk Management Process for the manufacturing site and associated products, ensuring that decision-making is informed by risk assessments.
- Guide the team through product and process investigations stemming from manufacturing issues, supplier challenges, material concerns, and audit-related complaints.
- Oversee the management of non-conforming products, ensuring adherence to established procedures for disposal and retention.
- Support transfer projects and new product introductions to guarantee compliance and effectiveness throughout execution.
- Analyze trends in products and processes to initiate corrective and preventive actions when necessary, contributing to continuous improvement plans.
- Provide expertise in statistical applications for validations and product evaluations.
- Ensure that all processes and procedures under their purview comply with the quality system, corporate policies, regulations, and other applicable requirements.
- Ensure timely and budget-compliant project completion.
- Assist the quality research and development team in implementing appropriate processes and products.
- Support the Site Quality Manager with Product Corporate Holds and necessary activities for distributed product analysis.
- Develop and manage quality engineers to ensure compliance with activities, fostering their knowledge and professional growth.
- Lead continuous improvement projects focused on product quality, patient safety, operational efficiency, and cost-effectiveness.
Qualifications:
- Bachelor's degree in Engineering or a related field.
- Minimum of 4 years of supervisory experience, including leadership and mentorship of engineering teams.
- At least 3 years of experience in manufacturing, with a preference for medical device manufacturing.
- Proficiency in English.
- Demonstrated experience with ISO13485, FDA QSR, and MDSAP regulations.
- Knowledge of ISO Risk Management principles.
- Strong understanding and experience in Process Validation.
- Statistical knowledge and application skills.
- Proficient in Microsoft Excel, Word, PowerPoint, Minitab, or similar software.
Cardinal Health is committed to fostering an inclusive workplace that values diverse perspectives and experiences. We encourage individuals from all backgrounds, including those with disabilities, veterans, and those without a college degree, to apply.
As an Equal Opportunity/Affirmative Action employer, Cardinal Health ensures that all qualified applicants receive consideration for employment without regard to race, religion, color, national origin, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, or any other status protected by law.
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