Associate Director overseeing Quality Assurance group for pharmaceutical manufacturing. Implementing cGMP practices and managing compliance for Devens and North Andover sites.
About the role
- Quality Engineer at Xylem improving product quality and driving initiatives for continuous improvement. Leading audits and collaborating across teams for high standards in manufacturing.
Responsibilities
- Lead root cause analysis and structured problem-solving to drive corrective and preventive actions.
- Manage and maintain CAPA and nonconformance systems to ensure compliance with internal and external standards.
- Serve as the facility-wide quality liaison with a focus on key value streams.
- Investigate product and process issues to improve efficiency and performance.
- Maintain and continuously improve the Quality Management System (QMS).
- Plan and conduct internal audits, mentor internal auditors, and coordinate external audits (ISO, NSF, UL).
- Prepare management review materials and track quality performance metrics.
- Deliver training on quality systems, procedures, and best practices.
- Partner with cross-functional teams, suppliers, and customers to drive improvement initiatives.
Requirements
- Bachelor’s degree in Quality Assurance, Mechanical Engineering, or a related technical field.
- Minimum 2-5 years of experience in manufacturing, engineering, and quality systems.
- Strong analytical, organizational, and communication skills.
- Expertise in root cause analysis, CAPA, and data-driven decision-making.
- Knowledge of ISO 9000, SPC, PPAP, calibration, and inspection systems.
- Experience with Lean Manufacturing and Continuous Improvement.
- Proficiency in root cause analysis and corrective action methodologies.
- Background in machine shop, plastics injection molding, or metal casting environments.
- Familiarity with CMMs, vision systems, and other automated measurement tools.
- Ability to interpret technical drawings, schematics, PPAP reports, and design documentation.
- Preferred: ASQ-CQE certification or willingness to obtain.
- Six Sigma Green Belt or Black Belt certification.
- Proficiency in Microsoft Office, Visio, Project Manager, Windchill, Salesforce, BPCS, ShopVue, Workday, and PC-DMIS.
Benefits
- Paid Volunteer Program
- Employee Resource Groups
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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