Quality Operations Manager

Role Overview

• Ensures the content and executional effectiveness of the QA Programs.
• Responsible to ensure products meet quality and efficiency standards set by the company.
• Develops quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories.
• Validates quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures.
• Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints.
• Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
• Direct and supervise Quality Assurance Team.
• Reviews and updates QMS SOPs, WIs, and Forms, as required, to match current practices.
• Maintains Major Equipment and Portable Equipment Log books.
• Maintains Non-TEP book (fills out when Non-TEP product is received).
• Collaborates with the Engineering Administrator and Director of Quality, to ensure compliant validation/qualification of all appropriate equipment and/or processes.
• Responsible for adherence to all Company policies and procedures.
• Works to improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions.
• Supervises a diverse workforce, @ 5-10 Quality Employees.
• Assists Human Resources with interviewing and managing performance.
• Ensures employees are trained according to their roles.
• Addresses complaints and problems, elevates to Leadership when needed.
• Ensures proper PPE’s and Safety procedures are followed.
• Instills a sense of quality through modeled quality behaviors and mindset.
• Flexibly works other shifts, shifts maybe 8, 10 or 12 hours as needed.

Requirements

• Bachelor’s degree, required or equivalent combination.
• 3-5 years Quality experience required.
• Supervision experience required.
• Experience in managing various levels of employees with different educational backgrounds, work style habits, and employment histories.