As Quality System Manager, you'll play a pivotal role in cultivating a Culture of Quality and Continuous Improvement across all departments by ensuring compliance with Quality System requirements. Your responsibilities will include owning and driving CAPAs, leading internal audits, and overseeing manufacturing process characterizations and validations (OQ and PQ).
Responsibilities Include:
- Establish and execute Quality strategic plans and policies.
- Oversee and develop Audits to help assure compliance to internal/external requirements, including customer requirements and strategic initiatives.
- Recommend, evaluate, and implement process changes that are designed to continually improve the quality management system (NCR, CAPA, Complaint, Doc Control, Lot Release).
- Lead Regulatory/customer audits.
- Lead staff to accomplish personal and organizational goals, adhere to policies/procedures and establish/maintain a 'culture of quality'.
- Assure that the Quality System is compliant with applicable Regulatory and Industry standards, specific to Medical Devices.
- Ensures timely resolution to customer inquiries (audit findings and complaints)
- Maintain Quality Metrics to demonstrate areas of improvement and state of compliance.
- Generate, review or approve Quality Assurance related documentation required for customer relationship/product development (such as: development, supply and quality agreement), verification of compliance, or for filings with regulatory bodies.
- Provide leadership and guidance to Quality Operations team.
- Manage Quality Direct Reports at site to ensure knowledge and execution of site Quality System
- Assure proper use of change management associated with validated processes.
- Reviews data, analyzes results and recommends changes based upon findings and performs follow up to verify effectiveness. .
- Performs other duties as assigned based on business needs.
Full-time employees become eligible for benefits on the first of the month following 30 days of continuous service. These benefits include:
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Employer-Paid Basic Life Insurance
- Supplemental Life Insurance
- Employer-Paid Short-Term Disability
- Long-Term Disability
- 401(k) Plan
- Paid Time Off
- Paid Holidays
