ZipRecruiter
Sr. Packaging and Labeling Product Engineer
ZipRecruiter, San Jose, California, United States, 95199
Job Description: The
Senior Packaging and Labeling Product Engineer
will lead critical packaging and labelling initiatives. This role is essential for driving compliance, innovation, and operational excellence for Global Medical Device. If you have expertise in
quality systems, regulatory compliance, project management , and
process improvement , we want to hear from you. This role will be located in San Jose, CA and have no direct reports. Role expectations
Quality Systems Oversight:
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.
Change Management:
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.
Process Improvement:
Identify opportunities for efficiency within labelling workflows and implement best practices. Drive continuous improvement to enhance compliance, productivity, and cost-effectiveness.
Technical Support and Troubleshooting:
Provide expertise in root cause analysis and corrective actions for packaging and labelling issues. Ensure specifications meet regulatory and process standards.
Cross-Functional Collaboration:
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. Travel approximately 30%.
What we're looking for
Education: Bachelor’s degree in Engineering, Regulatory Affairs, or a related field. Experience: Minimum 6 years of experience in global medical device and/or pharmaceutical packaging and labelling. Regulatory Knowledge: Deep understanding of global regulatory, legal, and carrier compliance standards. Technical Skills: Expertise in quality systems, label equipment and related end-to-end systems, artwork review, and regulatory compliance. Project Management: Proven ability to manage multiple projects effectively. Communication Skills: 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. Pay Transparency : If provided, base salary or wage rate ranges are the range in which Align reasonably expects to set a candidate’s pay for the posted position. Actual placement depends on the individual skills and experience level of a candidate plus the total compensation and equity across team members. For other locations outside of the primary location, the base salary range will be adjusted geographically. For Field Sales roles, the salary listed is the base pay only and does not include the applicable incentive compensation plan. A cost of living adjustment may be added to base pay for higher cost areas in the U.S. Our hourly rates are a standard pay determined based on the position and your location, year in school, degree, and experience. General Description of All Benefits
Align offers comprehensive benefits to full-time employees in this position. Family Benefits include medical, dental, and vision, with an HSA option for some plans. Align also offers the following: Discounts on Invisalign and Vivera to employees and their eligible dependents after 90 days of employment Back-up Child/Elder Care and access to a caregiving concierge Family Forming Benefits – Available to Employees and their spouse or domestic partner, covered under one of Align’s health plans Breast Milk Delivery and Lactation Support Services Employee Assistance Program Hinge Health Virtual Physical Therapy – Available to all employees and eligible dependents enrolled in an Align medical Plan Employee benefits: Align offers its employees a range of insurance options, a 401k plan with company match, employee stock purchase program, paid vacation and sick time, holidays, parental leave, bereavement leave, and other voluntary insurance options. Align complies with applicable state or local laws regarding benefits.
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Senior Packaging and Labeling Product Engineer
will lead critical packaging and labelling initiatives. This role is essential for driving compliance, innovation, and operational excellence for Global Medical Device. If you have expertise in
quality systems, regulatory compliance, project management , and
process improvement , we want to hear from you. This role will be located in San Jose, CA and have no direct reports. Role expectations
Quality Systems Oversight:
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.
Change Management:
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.
Process Improvement:
Identify opportunities for efficiency within labelling workflows and implement best practices. Drive continuous improvement to enhance compliance, productivity, and cost-effectiveness.
Technical Support and Troubleshooting:
Provide expertise in root cause analysis and corrective actions for packaging and labelling issues. Ensure specifications meet regulatory and process standards.
Cross-Functional Collaboration:
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. Travel approximately 30%.
What we're looking for
Education: Bachelor’s degree in Engineering, Regulatory Affairs, or a related field. Experience: Minimum 6 years of experience in global medical device and/or pharmaceutical packaging and labelling. Regulatory Knowledge: Deep understanding of global regulatory, legal, and carrier compliance standards. Technical Skills: Expertise in quality systems, label equipment and related end-to-end systems, artwork review, and regulatory compliance. Project Management: Proven ability to manage multiple projects effectively. Communication Skills: 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. Pay Transparency : If provided, base salary or wage rate ranges are the range in which Align reasonably expects to set a candidate’s pay for the posted position. Actual placement depends on the individual skills and experience level of a candidate plus the total compensation and equity across team members. For other locations outside of the primary location, the base salary range will be adjusted geographically. For Field Sales roles, the salary listed is the base pay only and does not include the applicable incentive compensation plan. A cost of living adjustment may be added to base pay for higher cost areas in the U.S. Our hourly rates are a standard pay determined based on the position and your location, year in school, degree, and experience. General Description of All Benefits
Align offers comprehensive benefits to full-time employees in this position. Family Benefits include medical, dental, and vision, with an HSA option for some plans. Align also offers the following: Discounts on Invisalign and Vivera to employees and their eligible dependents after 90 days of employment Back-up Child/Elder Care and access to a caregiving concierge Family Forming Benefits – Available to Employees and their spouse or domestic partner, covered under one of Align’s health plans Breast Milk Delivery and Lactation Support Services Employee Assistance Program Hinge Health Virtual Physical Therapy – Available to all employees and eligible dependents enrolled in an Align medical Plan Employee benefits: Align offers its employees a range of insurance options, a 401k plan with company match, employee stock purchase program, paid vacation and sick time, holidays, parental leave, bereavement leave, and other voluntary insurance options. Align complies with applicable state or local laws regarding benefits.
#J-18808-Ljbffr