Manufacturing Quality & Technical Manager

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

About Us

Accelerate the possible by joining a winning Amcor team that's transforming the packaging industry and improving lives around the world.At Amcor, we unpack possibility through our innovative and responsible packaging to provide solutions that benefit our customers, our people and our planet. More than 10,000 consumers worldwide encounter our products every second and rely on us for safe access to food, medicine and other goods. We value their trust by making safety our guiding principle. It's our core value and integral to how we do business.Beyond this core principle, our shared values and behaviors unite us as we work together to elevate customers, shape lives and protect the future. We champion our customers and help them succeed. We play to win - adapting quickly in an everchanging world - and make smart choices to safeguard our business, our communities and the people we serve for generations to come. And we invest in our world-class team, empowering our colleagues to unpack their potential, because we believe when our people grow, so does our business.

To learn more about playing for Team Amcor, visit www.amcor.com I LinkedIn I Glassdoor I Facebook I YouTube

Job Description

WHAT YOU GET TO DO

• The Quality & Technical Manager is the quality advocate for the plant, providing leadership in improving, monitoring and maintaining quality systems and programs, and supporting processes to ensure compliance to regulatory requirements for the industries we serve. Key drivers are assuring compliance to specifications on incoming materials, in-process conditions and finished products. Assures the ongoing reduction of quality attribute variation utilizing Statistical Process Control (SPC) methodology to improve the acceptance of our products by our customers. Serves as the point of contact with customers when product quality exceptions occur. Develops, implements and supports the plant's Quality Systems and Process Improvement projects to enable and assure production of a high quality product at a value that meets or exceeds our customer's requirements.
• Acts as a safety leader and puts safety first in all responsibilities. Works in conjunction with the EHS Manager to establish and maintain all policies and programs to assure a safe working environment.
• Provide hands‑on (roll up your sleeves) management of the elements of the Quality Management System. These include quality action plans, validations, customer complaints and internal holds, standard work, audit processes, document control, test methods, and quality test equipment. Ensure training is conducted for quality management system elements.
• Ensure plant systems are tied into corporate standards via reviews and audits.
• Generate scorecards and reports for all aspects of plant quality, not limited to and including VOC, CARs, SCARs, COAs, SPC reporting, losses, internal, and third party & customer audits.
• Ensure that quality systems satisfy and meet at all times all customer specifications, internal and regulatory requirements (ISO13485, GMP 21CFR part 820, FDA, Medical, Pharma etc.) applicable to industry.
• Conducts advanced statistical analysis and process capabilities for process and product quality.
• Independently manages customer interactions as it relates to product or service quality.
• Identify, define and promote awareness of customer requirements for the plant.
• Manages and trains the activities of the Quality Team including the lab/quality technicians.
• Performs all elements of supervision over direct reports - performance reviews, hiring, salary administration, training, recognition, discipline, etc.
• Directs activities and priorities of Process Engineers, and the Quality Department.
• Identifies, develops and implements plans for cost reduction, waste reduction, increased throughput and general process improvement.
• Ensures compliance and monitors resources for the maintenance and continuous improvement of the plant Product Quality Safety systems.
• Assists in Product Development by applying working knowledge of manufacturing capabilities to ensure design control and scale-up protocol is met at onset of any new project initiation.
• Site administrator of all incoming orders, specs, waivers, and Projects in Amcor Commercialization System. Administers the product specification system from the creation of new specs in conjunction with Sales and R&D to requesting revisions and / or deviations as required to optimize performance.
• Supervises internal validations to determine key process variables for the manufacturing processes.
• Carries out the necessary actions/steps to ensure new products conform to the Customers manufacturing and quality needs, and that it falls within our manufacturing process capabilities.
• Maintains overall Quality system/department in the facility by assuring current procedures and practices are appropriate to comply with customer requirements and specifications. Responsible for incoming verification of purchased products, in process inspection a