hat You Will Do:
Responsible for developing, establishing and maintaining the quality systems, programs, policies, processes, procedures and controls to ensure that the Huntington facility conforms to ISO standards, FDA regulations, customer requirements, and Ecolab standards.
- Implement, maintain, and comply with facility/corporate quality systems including ISO and FDA standards.
- Interface with company management to establish and maintain company Quality Policy and facility goals.
- Lead / Host external agency, customer and internal audits of the Huntington facility.
- Oversee site level quarterly Quality Steering Committee Meetings and Annual Management Review for facility compliance and assurance of policies and procedures as well as associated inputs and outputs of the meeting (site level metrics).
- Responsible for creating/reviewing/approving all Huntington Quality purchases/expenses.
- Address quality, service and cost issues at site level to assure customer satisfaction and compliance to regulations.
- Oversee site level management of quality system elements for: Incoming Inspection, In-Process (WIP) Inspection, Finished Goods release for distribution, CAPA System, Feedback / Customer Complaints, Internal Audit Program, Control of Non-Conforming Materials/Products and Quarantine Inventory, and Calibration Program.
- Responsible for developing/revising applicable standard operating procedures and work instructions specific to responsibilities within the Quality department as needed.
- Responsible for compliance with regulatory and ISO training requirements.
- Provide input into department budget, hiring and annual budgeting processes
- Oversee any investigations into process deviations and determine appropriate disposition as needed and assure compliance with quality system requirements.
- Oversee the functioning of the Huntington Quality Lab and ensure it meets the FDA standards.
- Perform other related duties as assigned.
- Bachelor's degree in a technical field, including engineering, biology, microbiology, or chemistry.
- 7+ years quality experience in manufacturing or RDE (research, development and engineering); minimum 5 years supervisory experience.
- No immigration sponsorship available
- Advanced degree in a technical field, including engineering, biology, microbiology, or chemistry.
- Knowledge of manufacturing of regulated products including medical devices, cosmetics, pharmaceutical products.
- Knowledge of financial measurements
- Strong computer literacy and demonstrated use of technology to improve logistics performance.
- Project management experience
- Certified Quality Auditor Certification (ASQ CQA)
- Certified Manager of Quality Certification (ASQ CQM/OE)
- 2+ years' experience in a continuous improvement environment (Lean, Six Sigma, TPM, and/or 5S experience –