- Ensuring compliance with all Federal, State & Local regulatory requirements for products manufactured at the New York site.
- Act as the Quality Assurance lead and management representative for the site.
- Manage and enhance the quality management system at the site.
- Provide leadership in quality assurance for various functions including quality systems maintenance, material and product release, supply chain, automation, validation, complaints, deviations, CAPAs, and facility engineering.
- Develop and implement quality procedures to support commercial cGMP production.
- Supervise quality systems during daily production to maintain high product quality.
- Lead internal and external audits, and regulatory inspections at the site.
- Maintain and present Key Performance Indicators and Quality Metrics to Operations and Senior Quality Leadership monthly.
- Manage quality assurance personnel, including recruitment, training, and development to ensure compliance with cGMP and business objectives.
- Oversee vendors and suppliers, including auditing as required.
- Represent the site and company at external events, conventions, seminars, and trainings.
- Minimum 10+ years of experience in the medical devices or biopharmaceutical industries.
- Must have 5+ years of quality assurance management/supervisory experience
- Must have working knowledge of current Good Manufacturing Practices (cGMP), FDA regulations and guidance, and 21 CFR 210, 211, and 820.
- Ability to work with a multidisciplinary team and establish working relationships both internally and externally.
- Must be proficient in the use of Microsoft Excel, Microsoft Word, Outlook, and PowerPoint.
- Experience in hosting regulatory audits/inspections is preferred.
- Ability to read, understand, and write highly technical material.
- Proficient in reading, writing, and communicating in the English language.
- Bachelors degree in life sciences or related field
- Advanced degree is a plus
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Quality Assurance Manager - North Tonawanda, United States - a Medical Devices equipment company located in New York
1 week ago
Description
Quality Assurance Manager
RESPONSIBILITIES
QUALIFICATIONS
EDUCATION
