Responsible in assisting the Quality Manager on the department activities such as yearly goals, objectives, department budget, identify of the areas of opportunity, implement Quality Systems and maintain the facility within GMP compliance and FDA regulations. Develop and update the inspection procedures and methods used for product quality evaluation. Responsible for the Quality and compliance of new BPS converted lines. Develop and execute the product and process validation, conduct customer complaint evaluation and participate with the internal audits as needed.
Summary of Position with General Responsibilities
• Implement appropriate and efficient preventive and corrective actions to avoid problems • Product and process validations within the facility and external suppliers (IQ/OQ & PQ) including testing equipment and tooling. • Interact with corporate and divisional personnel to clarify specifications, product design changes, quality issues and line reconfigurations. • Ensure GMP regulations and ISO and corporate guidelines are followed.
Knowledge & Training: Knowledge in statistical techniques, GMP’s and QA basics, QSR and ISO requirements. Green Belt Cert. desired
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C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 13,000 people around the world. Founded in 1907, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Bard is a M/F, Disabled and Vet EEO/AA Employer.
Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.