Job Description

Job Title: Quality Manager

POSITION SUMMARY:

This position is responsible for ensuring the continued success and development of the local Quality Team and maintaining and improving the Quality Management System (QMS) in accordance with the company, ISO, and (as applicable) API guidelines.

ESSENTIAL DUTIES AND OTHER RESPONSIBILITIES:

• Lead and develop the local Quality team, while aligning with enterprise Quality functions to drive a positive, consistent, high-performing Quality culture across operations and support functions.
• Own and continuously improve the QMS to ensure compliance with ISO 9001 and applicable API standards, while enhancing effectiveness, scalability, and audit readiness.
• Promote and enforce robust processes for Quality event management, including nonconformance handling, risk assessment, root cause analysis, and corrective/preventative actions (CAPA), ensuring timely closure, verified effectiveness, and sustained Quality at the Source.
• Monitor and report Quality Key Performance Indicators (KPIs), translating data into actionable insights and driving accountability for gap closure.
• Communicate requirements and customer concerns to the team in an effective, professional manner.
• Manage supplier audits and their processes in accordance with the company guidelines.
• Interface with others both internal and external to the company and communicate quality challenges in a professional and effective manner.
• Manage the facility’s equipment calibration program and verify that available equipment is sufficient to ensure conforming output.
• Manage the external testing of materials and products as required.
• Prepare and manage department budget.
• Perform other duties as assigned by leadership.

QUALIFICATIONS:

EDUCATION AND/OR EXPERIENCE:

• High School Diploma or equivalent required; Bachelor’s degree preferred.
• 3 years’ experience in a lean environment, Lean Six Sigma Green Belt preferred.
• Effective coaching and mentoring skills, Management or Demonstrated Leadership Experience preferred.
• Must have data analysis, critical thinking, and problem-solving skills.
• Ability to work within and be an active member of cross-functional teams.
• Experience with implementation and sustainment of Quality Systems.

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