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Associate Medical Device Labeling Jobs in California

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... of critical parts, labeling activities, and quality non-conformance, accurately and timely ... Minimum 2 years related experience Medical device or diagnostics industry preferred * Familiarity ...

New

Project Manager - Medical Device

Irvine, CA · On-site +1

$81K - $115K/yr

... labeling required for the Design History Files of medical devices. * Determines and tracks ... Minimum three (3) years of experience in project management; medical device industry experience, a ...

Labeling Program Manager

Los Angeles, CA · On-site

$121K - $205K/yr

Previous experience in medical device industry * Cross functional leadership and collaboration across highly matrixed organization * Experience with labeling systems and printer * PMP or equivalent ...

Previous experience in medical device industry * Cross functional leadership and collaboration across highly matrixed organization * Experience with labeling systems and printer * PMP or equivalent ...

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Assess manufacturing changes, product line extensions, technical documentation, and labeling for regulatory impact. * Interpret applicable medical device regulations, guidance documents, and ...

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Assess manufacturing changes, product line extensions, technical documentation, and labeling for regulatory impact. * Interpret applicable medical device regulations, guidance documents, and ...

Three (3) years of experience in a medical device or pharmaceutical FDA regulated environment producing technical documentation. * Three (3) years of experience in labeling and digital design ...

Showing results 21-40

Associate Medical Device Labeling information

What is an associate medical device labeling?

Associate Medical Device Labeling professionals are responsible for creating, reviewing, and maintaining the labeling and packaging materials for medical devices. Their work ensures that all product information, instructions, and regulatory warnings are accurate, clear, and compliant with industry regulations. They collaborate closely with regulatory affairs, quality assurance, and product development teams to make sure that labels meet local and international standards. This role is critical in helping ensure patient safety and regulatory approval of medical devices.

What are the key skills and qualifications needed to thrive as an associate medical device labeling?

To thrive as an Associate Medical Device Labeling Specialist, you need a strong understanding of regulatory requirements, attention to detail, and experience in technical writing, often supported by a degree in life sciences or a related field. Familiarity with labeling software, document management systems, and knowledge of FDA or EU MDR regulations are typically required. Excellent communication, collaboration, and organizational skills set top performers apart in this position. These skills are crucial to ensure label accuracy, regulatory compliance, and patient safety in a highly regulated industry.

What are some common challenges faced by associate medical device labeling, and how can they be addressed?

Associate Medical Device Labeling professionals often encounter challenges such as keeping up with evolving regulatory requirements across different countries, ensuring accuracy and clarity in complex technical information, and coordinating input from multiple departments like regulatory affairs, engineering, and marketing. Addressing these challenges involves staying updated on global labeling standards, developing strong attention to detail, and building effective communication and collaboration skills. Leveraging project management tools and regularly participating in training can also help manage these complexities and ensure timely, compliant labeling deliverables.

What cities in California are hiring for Associate Medical Device Labeling jobs?

Cities in California with the most Associate Medical Device Labeling job openings:

Packaging and Labeling Technician - Shockwave Medical

Johnson & Johnson

Santa Clara, CA • On-site

$20 - $24.25/hr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 16 days ago


Johnson & Johnson rating

8.3

Company rating: 8.3 out of 10

Based on 113 frontline employees who took The Breakroom Quiz

25th of 86 rated pharmaceutical


Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Supply Chain Manufacturing

Job Sub Function:

Production Equipment Repair & Maintenance

Job Category:

Business Enablement/Support

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Packaging and Labeling Technician - Shockwave Medical to join our team located in Santa Clara, CA.

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview

The Packaging/Labeling Technician performs complex or specialized technical assignments usually in the nature of projects, which requires the ability to work independently. Uses considerable judgment, a high degree of initiative, creative approaches in troubleshooting, and adapts to rapidly shifting priorities and a fast-paced environment. The Packaging/Labeling Technician monitors and improves manufacturing processes related to Packaging, Labeling, & printing and makes recommendations for continuous improvement of work processes for Manufacturing Engineering.

Essential Job Functions

  • Accountable for labeling and packaging equipment, process, and materials improvement

  • Evaluates and analyzes manufacturing processes to find ways to improve efficiency and quality.

  • Identifies opportunities to improve product flow, 5S, and mistake proofing in the manufacturing/packaging process, and implements process improvements alongside engineers

  • Set up, operate, maintain, inspect & clean all packaging equipment (e.g., printing, inspection system/tools, sealing machine, and package equipment) according to standard operating procedure and manuals.

  • Assist in execution of equipment validations (IO, OQ. &PQ)

  • Provides support data to Engineers for feasibility, qualification and/or validation studies.

  • Assist in drafting Standard Operating Procedure for labeling and packaging equipment

  • Assist in design or improving packaging components for existing or up-coming products

  • Draft specification for packaging designs and components

  • High attention to detail in updating documents and reviewing documents/workflows

  • Assist in designing and formatting of product labels for new and existing medical device products in compliance with medical, legal, internal, and external regulatory requirement

  • Draft label specification for product labels

  • Proof labeling material documents against source files to ensure meet established specifications.

  • Assist in the routing of product labels changes for review and approval in change control system,

  • Investigate and troubleshoot complex labeling issues

  • Proficiency in Microsoft Office Word, Excel, & Outlook

  • Proficiency with Adobe Professional Product and label design software (Seagull Bartender)

  • Availability for occasional Saturday production support may be required based on business needs.

  • Other duties as assigned.

  • These job requirements are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel.

Requirements

  • High School diploma or GED or equivalent experience

  • Minimum of three (3) years' of experience in a medical device environment or equivalent experience in a similar work environment.

  • Knowledge of and experience with: Quality System requirements (e.g., QSRs, ISO, MDD).

  • Knowledge of label and barcode standards and specification (e.g. GTN, GS1, ISO 15416, 1D & 2D barcode, etc.)

  • Understanding and experience with 5S, Lean and waste reduction in manufacturing.

  • Experience with equipment preventive maintenance and or calibration a plus.

  • Written and verbal communication skills to communicate effectively at all levels.

  • Ability to work in a fast-paced environment while managing multiple priorities

  • Operate as a team and/or independently while demonstrating flexibility to changing

  • requirements.

  • There may be continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day)

  • Employee may be required to lift objects up to 25lbs or more. Employees will be required to work in an air-conditioned office space and possibly perform some tasks in our non-controlled temperature warehouse space.

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as assigned or negotiated to meet the ongoing needs of the organization.

Additional Information

  • The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

  • Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

  • Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

  • Employees are eligible for the following time off benefits:

    • Vacation - up to 120 hours per calendar year

    • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year

    • Holiday pay, including Floating Holidays - up to 13 days per calendar year

    • Work, Personal and Family Time - up to 40 hours per calendar year

  • Additional information can be found through the link below.https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Agile Manufacturing, Analytical Reasoning, Detail-Oriented, Equipment Maintenance, Good Manufacturing Practices (GMP), Issue Escalation, Manufacturing Equipment, Plant Operations, Predictive Maintenance, Problem Management, Process Oriented, Product Installation, Professional Ethics, Repair Management, Time Management, Troubleshooting

The anticipated base pay range for this position is :

$40,250.00 - $64,802.50

Additional Description for Pay Transparency:


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