- Coaches, mentors, and leads all employees in the Quality Assurance Manager's areas of responsibility to achieve goals and objectives related to quality control, quality assurance, customer demands, and customer specifications.
- Drives quality certifications and takes the lead on all audits (ie: ISO). Renews and maintains all documentation regarding certifications and other company licenses concerning quality control and assurance.
- Investigates all complaints, documents and makes recommendation for corrective actions, and ensures that proper follow up is taken. Shares all information with appropriate managers and personnel.
- Creates and implements KPI's for quality assurance and quality control.
- Creates, implements, and ensures compliance with all company controlled documents as it relates to quality assurance and quality control (SOPs, Guidelines, Process Descriptions, and Forms and Checklists).
- Ensures all employees work according to the company's cGMP and ISO standards.
- Creates and maintains performance indicators, quality benchmarks, and measures performance on the quality assurance department (ie: deviations and non-conformations).
- Creates all QA testing, performance indicators, and benchmarks for all projects.
- Works with the Operation Manager to help to lead continuous improvement activities and procedures to ensure efficient and compliant processes. Implements new procedures and policies in order to improve quality.
- 5-7 years' experience with quality engineering and management preferably in a manufacturing environment.
- Knowledge of cGMP/QSR,
- Experience with Lean Manufacturing principles, 5S and other productivity and quality improvement methods.
- Intermediate to advanced level of computer knowledge in the Microsoft Office Suites.
- Reading, analyzing, and interpreting technical procedures, manuals and manufacturing documents including financial data as it relates to investments and personnel.
- Bachelor's Degree in Science, Engineering or other related field.
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Quality Assurance Manager - New York, United States - Schreiner Group
Description
Schreiner Group LPhas a full-time regular position for a
Quality Assurance Manager.
RESPONSIBILITIES:
EXPERIENCE :
ISO:
9001,
ISO:
14001,
ISO:
45001, IATF 16949 and FDA device/drug/biologics regulations.