Quality & Technical Manager – Medical Device Manufacturing

amcor; California; On-site; USD 120,000 - 170,000; Full time

Job summary

Amcor is seeking a Quality & Technical Manager to lead plant quality systems, drive SPC-based continuous improvement, and ensure compliance with ISO13485, GMP 21 CFR 820, FDA, and pharmaceutical industry standards. You will supervise the quality team, coordinate with EHS, and partner with Sales/R&D to deliver high-quality products while reducing defects and waste.

Responsibilities include implementing QA programs, auditing processes, generating scorecards, and maintaining documentation control,

Qualifications

• Experience leading quality management systems in a manufacturing setting.
• Strong data analysis and SPC skills.
• Knowledge of regulatory frameworks (ISO13485, GMP 21 CFR 820, FDA) and pharma industry standards.

Responsibilities

• Lead the plant Quality Management System and ensure compliance with specifications.
• Act as safety leader in conjunction with EHS and promote safe working environment.
• Develop, implement, and maintain quality programs, training, audits, and documentation control.
• Generate scorecards/reports for VOC, CARs/SCARs, COAs, SPC, and audits.
• Manage quality team, including lab/quality technicians, and supervise daily activities.

Skills

Quality management

SPC (statistical process control)

Process improvement

Leadership

Regulatory compliance

Customer communication

Job description

Amcor is seeking a Quality & Technical Manager to lead plant quality systems, drive SPC-based continuous improvement, and ensure compliance with ISO13485, GMP 21 CFR 820, FDA, and pharmaceutical industry standards. You will supervise the quality team, coordinate with EHS, and partner with Sales/R&D to deliver high-quality products while reducing defects and waste.

Responsibilities include implementing QA programs, auditing processes, generating scorecards, and maintaining documentation control,