Quality Assurance Manager

Schreiner Group LP has a full-time regular position for a Quality Assurance Manager.

RESPONSIBILITIES:

· 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.

EXPERIENCE:

· 5-7 years’ experience with quality engineering and management preferably in a manufacturing environment.

· Knowledge of cGMP/QSR, ISO:9001, ISO:14001, ISO:45001, IATF 16949 and FDA device/drug/biologics regulations.

· 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.