Job Description

We are seeking an experienced Plant Quality Manager to lead quality operations at our manufacturing facility. This role will drive improvements across Quality, Delivery, Cost, and Customer Service by fostering a plant-wide culture of quality and continuous improvement.

Key Responsibilities:

Quality Leadership & Management

• Lead all plant quality functions including Quality Control, Metrology, Engineering, and Validation
• Build and manage a high-performing quality team
• Partner with Plant Leadership and Corporate Quality to drive operational excellence
• Represent the plant in customer communications, audits, and regulatory inspections

Quality Systems & Compliance

• Oversee implementation and improvement of site-level and corporate QMS procedures
• Ensure audit readiness and lead execution of internal/external audit programs
• Maintain compliance with ISO 13485, ISO 9001, CFR Part 820, and MDSAP standards
• Conduct training, DOE studies, statistical analysis, and process qualifications

Customer & Operational Support

• Support day-to-day operations through troubleshooting and continuous improvement
• Operate and maintain Quality Control and metrology labs
• Work cross-functionally with Operations and Engineering on validation and SPC

Team Development & Culture

• Coach and mentor teams on quality principles, metrics, and systems
• Develop and execute training and communication plans for quality awareness
• Set performance goals for the Quality team and manage HR-related processes

Qualifications:

• Bachelor’s degree in Engineering, Science, Business, or related field
• 7+ years in Plant Quality Operations or QMS implementation
• 5+ years of experience managing salaried/hourly quality teams
• Deep understanding of ISO 13485 , ISO 9001, CFR Part 820 , and MDSAP
• Experience in plastics processing, packaging, pharma, or medical device industries
• Proficient in statistical analysis, validation, DOE, and SPC
• Experience with ERP and QMS tools (e.g., IQMS, Microsoft Excel, Word)

Certifications (Preferred):

• ASQ Certified Quality Manager (CQM/OE) or Certified Quality Auditor (CQA)

Key Skills:

• Strong analytical, communication, and organizational skills
• Ability to coach, mentor, and lead cross-functional teams
• High attention to detail with ability to manage multiple priorities
• Comfortable in a fast-paced, regulated manufacturing environment
• Able to interface with customers and regulatory authorities professionally

Ready to lead plant-wide quality performance and drive impactful results? Apply now and join a mission-driven team focused on operational excellence.

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