Senior Quality & Technical Manager (Medical Devices)

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

Benefits offered by this job

Medical coverage

Paid time off

Holidays

Wellbeing program

Job summary

Amcor is seeking a Quality & Technical Manager in California to lead the plant's quality systems and drive process improvements. You will oversee quality actions, validations, customer feedback, and internal holds, ensuring compliance with ISO13485, GMP 21CFR 820, FDA and related standards while promoting a culture of continuous improvement.

You will manage a quality team, interact with Sales, R&D and Manufacturing, and lead cost and waste reduction initiatives to deliver high-quality products

Qualifications

• ASQ CMQ/QE or ASQ CQE certification preferred.
• Minimum of five to ten years in manufacturing QA/QC and Operations/Production.
• Ten years 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.
• Familiar with GMP 21CFR part 820, FDA, ISO13485/medical validation.
• Bilingual English/Spanish proficiency.

Responsibilities

• Lead safety initiatives and partner with EHS to maintain a safe working environment.
• Hands-on management of the Quality Management System elements and trainings.
• Ensure plant systems align with corporate standards via reviews and audits.
• Generate scorecards and reports for VOC, CARs, SCARs, COAs, SPC, and audits.
• Maintain compliance with customer specs and regulatory requirements.
• Perform advanced statistical analysis and assess process capabilities.
• Interact with customers regarding product quality issues.
• Develop and promote awareness of customer requirements.

Skills

Quality leadership

Statistical analysis

Regulatory knowledge

Bilingual English/Spanish

Education

ASQ CMQ/QE or ASQ CQE certification

Tools

Excel

PowerPoint

Word

Outlook

Minitab

SAP

Job description

Amcor is seeking a Quality & Technical Manager in California to lead the plant's quality systems and drive process improvements. You will oversee quality actions, validations, customer feedback, and internal holds, ensuring compliance with ISO13485, GMP 21CFR 820, FDA and related standards while promoting a culture of continuous improvement.

You will manage a quality team, interact with Sales, R&D and Manufacturing, and lead cost and waste reduction initiatives to deliver high-quality products