Maxonic Inc. · 1 week ago
Senior Packaging and Labeling Product Engineer
San Jose, CA
Full-time
Onsite
Senior Level
5+ years expMaxonic Inc. is a company specializing in quality systems for packaging and labeling in the medical device and pharmaceutical sectors. The Senior Packaging and Labeling Product Engineer will maintain and enhance quality systems, lead change management, and collaborate across various teams to ensure compliance and efficiency in packaging and labeling processes.
ConsultingHuman ResourcesInformation TechnologyRecruiting
Hiring Manager
Surya Prakash
Responsibilities
Maintain and enhance packaging and labelling quality systems in compliance with Global Regulatory and Legal requirements
Develop and refine SOPs, work instructions, and other quality documentation
Lead change management for packaging and labelling, ensuring smooth implementation of lifecycle changes
Review and manage label change requests (LCR) to ensure compliance and timely updates
Manage packaging and labelling initiatives from concept to implementation
Develop scopes, timelines, and risk mitigation strategies to ensure compliance with regulatory standards
Identify opportunities for efficiency within labelling workflows and implement best practices
Drive continuous improvement to enhance compliance, productivity, and cost-effectiveness
Provide expertise in root cause analysis and corrective actions for packaging and labelling issues
Ensure specifications meet regulatory and process standards
Collaborate with quality assurance, regulatory affairs, manufacturing, engineering, operations, product management, PMO, and supply chain teams
Support product launches and regulatory updates to achieve timely and compliant product releases
Qualification
Required
Bachelor's degree in Engineering, Regulatory Affairs, or a related field
Minimum 5 years of experience in global medical device and/or pharmaceutical packaging and labelling
Deep understanding of global regulatory, legal, and carrier compliance standards
Expertise in quality systems, label equipment and related end to end systems, artwork review, and regulatory compliance
Proven ability to manage multiple projects effectively
Strong collaboration and influencing abilities across departments
Experience with implementation and execution of program and enterprise risk management
Familiarity with Root Cause Analysis and Operational Excellence methodologies such as LEAN, DMAIC, Six Sigma
Company
Maxonic Inc.
Maxonic, Inc. is a certified minority-owned technology consulting and staffing firm founded in 2002.
201-500 employees
H1B Sponsorship
Maxonic Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2022 (2)
2021 (4)
2020 (4)
Funding
Current Stage
Growth StageCompany data provided by crunchbase