Quality & Technical Leader – Medical Devices (GMP/GxP)

Amcor; Commerce (CA); On-site; USD 98,000 - 135,000; Full time

Benefits offered by this job

Medical, dental and vision plans

401(k) with company match

Paid Parental Leave

Tuition Reimbursement

Discretionary annual bonus

Wellbeing program

Job summary

Amcor Commerce Healthcare Packaging CA seeks a Quality & Technical Manager to lead quality programs, drive regulatory compliance, and guide continuous improvement. You will manage the Quality Management System, liaise with customers on quality matters, and oversee the quality team and process engineers to ensure high-quality products that meet customer requirements.

The role emphasizes SPC-based improvements, audits, and cross-functional collaboration with Sales, R&D, and Manufacturing to uphold

Qualifications

• ASQ CMQ/QE or ASQ CQE certification preferred.
• Minimum of five (10) years of manufacturing experience including QA/QC and Operations/Production.
• 7 years’ experience in Technical and Quality Management with medical device experience.
• 2–3 years in a Leadership/Supervisory role.
• Demonstrated project management experience.
• Knowledge of Quality System Software and Quality Engineering tools.
• Thorough understanding of GMP 21CFR part 820, FDA, ISO13485/medical validation; includes Statistical Analysis, DOE, Pareto charts, Histograms.
• Proficient with PC tools: Excel, PowerPoint, Word, Outlook; Minitab and SAP a plus.
• Bilingual - English/Spanish speaking required.

Responsibilities

• Act as a safety leader and prioritize safety in all duties.
• Manage elements of the Quality Management System and ensure staff training.
• Align plant systems with corporate standards through reviews and audits.
• Generate scorecards and reports for quality metrics and audits.
• Ensure compliance with ISO13485, GMP, FDA, and other regulatory standards.
• Conduct advanced statistical analysis and capability studies.
• Lead customer interactions regarding product quality.
• Define and promote customer requirements for the plant.
• Oversee quality team and lab personnel; supervise performance and development.
• Direct Process Engineers and Quality Department priorities.
• Identify cost and waste reduction opportunities and drive improvements.
• Maintain quality systems and procedures to meet customer specs.

Skills

Leadership

Communication

Analytical Skills

Team Leadership

Problem Solving

Quality Systems Knowledge

Bilingual - English/Spanish

Education

ASQ CMQ/QE or ASQ CQE certification

Tools

Minitab

SAP

Excel

PowerPoint

Word

Outlook

Job description

Amcor Commerce Healthcare Packaging CA seeks a Quality & Technical Manager to lead quality programs, drive regulatory compliance, and guide continuous improvement. You will manage the Quality Management System, liaise with customers on quality matters, and oversee the quality team and process engineers to ensure high-quality products that meet customer requirements.

The role emphasizes SPC-based improvements, audits, and cross-functional collaboration with Sales, R&D, and Manufacturing to uphold