Job Description
Job Description
Job Description
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 ~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 internship 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 We are pleased to provide a general description of the benefits Align offers to full-time employees in this position.
Family Benefits. Align offers employees and their eligible dependents medical (with a Health Savings Account option for some plan offerings), dental, and vision in accordance with those plans. Align also offers to employees:
- 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 (age 18+) enrolled in an Align medical Plan
Employee benefits. Align offers its employees:
- Short-term and long-term disability insurance in accordance with those plans.
- Basic Life Insurance and Accidental Death and Dismemberment. Voluntary Supplemental Life Insurance for Employee, Spouse/Domestic Partner, and Child(ren) are available for purchase in accordance with those plans.
- Flexible Spending Accounts – Employees may be eligible to participate in a health care account (including a limited health FSA if enrolled in a HDHP), dependent care account, and a pre-tax commuter benefit plan.
- 401k plan (with a discretionary Company match of 50% up to 6% of eligible earnings up to a maximum match of 3%.). Employer match vests after two years – 25% year one and 100% at year two. Align offers traditional, Roth, and after-tax options.
- Employee Stock Purchase Program (Employees must work 20 hours or more and be employed on purchase date to be eligible).
- Paid vacation of up to 17 days during the first full year of employment (currently accrued at the rate of 5.24 hours each pay-period), which carries over to a maximum cap of 30 days. Annual paid vacation time accrual increases based on tenure. Both exempt and non-exempt employees who work 32 hours or more per week receive prorated vacation accrual based on their regularly scheduled work hours and tenure.
- Sick time is accrued throughout the year at the rate of one hour for every thirty worked. Employees can carry over unused sick leave each year, up to a maximum balance of 80 hours.
- 11 Company-designated paid holidays throughout the year.
- If employed for at least 12 consecutive months, Align will grant up to 6 weeks of paid Parental Leave. If employed for less than 12 consecutive months, Align will grant up to 4 weeks of paid Parental Leave. All parental leave must be completed within one year of the birth or placement of the child. Parental leave is in addition to any state and/or local parental leave benefits. Three days of paid bereavement leave. In some cases, due to travel the amount of paid leave may be extended to 5 paid days off. To the extent applicable state or local law offers more generous benefits, Align complies with any such law.
- Non-exempt employees will receive full pay for up to 10 days of jury duty. Exempt employees will receive their full salary during any week they serve and perform any work. Other insurance such as legal, critical illness, voluntary accident, long-term care, auto, home and pet insurance are available for purchase.
To the extent applicable state or local law offers more generous benefits, Align complies with any such law.
Job Tags
Hourly pay, Full time, Temporary work, Internship, Local area, Flexible hours