Vacancy caducado!
Manage plant quality systems (including ISO documentation, records retention, etc.) and plant quality personnel to ensure that plant product and process compliance to regulatory, customer and company standards.
- Responsible for ensuring regulatory compliance to all aspects of ISO13485 and 21 CFR 820 and all applicable regulations and guidance documents.
- Leads all quality teams (Quality Assurance, Quality Engineering and Quality Control leads.)
- Continuously improves quality function spending to help the plant lower its costs.
- Oversees the validation program and directly supports the Solutions Plant Quality Manager with regard to the site risk management procedure.
- Provide support for the regulatory approval for the manufacture of custom products; gathers necessary information regarding intended use of product and supports regulatory approval for development and labeling of new products and supports regulatory approval for all documents-both technical/marketing and controlled documents as needed.
- REQUIRED: Bachelor’s degree (preferable in Life Sciences, Chemistry or Engineering)
- 5+ years quality, engineering or operations experience within a manufacturing environment.
- At least 2+ years of managerial or supervisory experience.
- Audit/inspection experience and familiarity with 21 CFR parts, 820, 210/211, ISO13485 preferred.
- Strong knowledge base in all aspects of Quality (including validation, calibration, and quality control.)
Vacancy caducado!