Manufacturing Quality & Technical Manager

Amcor•AF Commerce Healthcare Packaging CA, CA

1d•$98,000 - $134,750

About The Position

The Quality & Technical Manager serves as the plant’s quality advocate, leading the improvement, monitoring, and maintenance of quality systems and programs while supporting compliance with applicable regulatory requirements. The role ensures specifications are met for incoming materials, in-process conditions, and finished products; reduces quality variation using Statistical Process Control (SPC); and serves as the customer point of contact for product-quality exceptions. The manager develops and supports quality systems and process-improvement projects to ensure high-quality products meet or exceed customer requirements. This position is a hands-on leader of the plant Quality Management System, including quality action plans, validations, customer complaints, internal holds, standard work, audits, document control, test methods, and quality test equipment. It leads the Quality Team and lab/quality technicians, supervises direct reports, and directs the priorities of Process Engineers and the Quality Department. The role also works across Sales, R&D, Manufacturing, Supply Chain, Customer Service, and customers on specifications, product development, corrective actions, and quality expectations. It is an active member of the plant leadership team and promotes a culture of safety and continuous improvement.

Requirements

Minimum of five (10) years of manufacturing industry experience, including positions in both quality QA/QC and Operations/Production, as stated in the posting.
Seven years of experience or involvement in Technical and Quality Management with medical device experience.
Two to three years of demonstrated achievement in a leadership or supervisory position.
Demonstrated project management experience.
Knowledge of Quality System Software and Quality Engineering tools.
Thorough understanding of GMP 21 CFR Part 820, FDA, and ISO 13485, including medical validation experience.
Knowledge of quality and problem-solving tools, including statistical analysis, DOE, Pareto charts, and histograms.
Strong proficiency in PC-based tools, including Excel, PowerPoint, Word, and Outlook.
Bilingual English/Spanish speaking required.
Effective communication skills to execute quality programs and communicate with employees at all levels of the plant.
Exceptional problem-solving and analytical skills, including the ability to make quick and appropriate decisions.
Strong collaboration, influencing, and customer-service skills.
Strong team leadership skills, including the ability to manage, coach, and develop people, talent, and skills.
Demonstrate energy, empowerment, and execution, and live Amcor Core Values by leading through example.

Nice To Haves

ASQ CMQ/QE or ASQ CQE certification preferred.
Minitab experience is a plus.
Previous SAP experience is a plus.

Responsibilities

Act as a safety leader and work with the EHS Manager to establish and maintain policies and programs for a safe working environment.
Manage the elements of the Quality Management System, including action plans, validations, customer complaints, internal holds, standard work, audit processes, document control, test methods, and quality test equipment; ensure training is conducted on these elements.
Ensure plant systems align with corporate standards through reviews and audits.
Generate scorecards and reports on plant quality, including VOC, CARs, SCARs, COAs, SPC reporting, losses, and internal, third-party, and customer audits.
Ensure quality systems meet customer specifications and internal and regulatory requirements, including applicable ISO 13485, GMP 21 CFR Part 820, FDA, medical, and pharmaceutical requirements.
Conduct advanced statistical analysis and assess process capabilities for process and product quality.
Manage customer interactions independently regarding product or service quality, and identify and promote awareness of customer requirements at the plant.
Manage and train the Quality Team, including lab and quality technicians; perform supervisory duties for direct reports, including performance reviews, hiring, salary administration, training, recognition, and discipline.
Direct the activities and priorities of Process Engineers and the Quality Department.
Develop and implement plans for cost reduction, waste reduction, increased throughput, and process improvement.
Ensure compliance with and monitor resources for maintaining and continuously improving plant Product Quality Safety systems.
Support product development by applying knowledge of manufacturing capabilities to design control and scale-up protocols at project initiation.
Administer incoming orders, specifications, waivers, and projects in the Amcor Commercialization System; manage product specifications from creation with Sales and R&D through revisions or deviations.
Supervise internal validations to determine key process variables for manufacturing processes.
Ensure new products meet customer manufacturing and quality needs and fit manufacturing capabilities.
Maintain the facility’s overall quality system and department, ensuring procedures and practices comply with customer requirements and specifications; oversee incoming verification, in-process inspection, and final product review.
Adhere to relevant Environmental, Health and Safety policies and procedures.
Liaise among Sales, R&D, Manufacturing, and customers on quality expectations, customer-site performance, and manufacturing capabilities, keeping relevant parties informed.
Manage the Corrective Action system and assist Supply Chain, Customer Service, Customer Focused Quality, and manufacturing groups in resolving quality concerns and complaints.
Participate in and lead teams supporting continuous-improvement initiatives, and establish a continuous-improvement culture in Quality.
Serve as an active member of the plant leadership team.

Benefits

Medical, dental, and vision plans.
Flexible time off, starting at 80 hours paid time per year for full-time salaried employees.
Company-paid holidays, starting at 8 days per year and varying by location.
Wellbeing program and Employee Assistance Program.
Health Savings Account and Flexible Spending Account.
Life insurance, AD&D, short-term and long-term disability, and voluntary benefits.
Paid Parental Leave.
Retirement Savings Plan with company match.
Tuition Reimbursement, dependent upon approval.
Discretionary annual bonus program; initial eligibility depends on hire date.
Position may be eligible for the Management Incentive Plan or Sales Incentive Plan, an annual bonus program based on business and individual performance.