Labeling and Documentation Specialist

Labeling and Packaging Quality Specialist responsible for accurate, compliant labeling and packaging for Image Guided Therapy medical devices within global regulatory requirements.

Job Requirements

• Bachelor’s degree or equivalent relevant experience in a related discipline

• Proficiency in Adobe Creative Suite

• Proficiency in Microsoft Office

• Experience developing and maintaining Instructions For Use (IFUs), including product illustrations, layout design, and copy

• Experience performing prepress activities to prepare labeling artwork files for accurate output

• Experience using Product Lifecycle Management (PLM) systems (e.g., Windchill) for document control and routing for approval

Preferred Skills

• Experience with Adobe LiveCycle

• Exposure to Bartender labeling software

• Exposure to EnLabel

• Exposure to Windchill and/or SAP

• Knowledge of regulatory standards including FDA, EU MDR, Japan, Canada, and applicable ISO standards

Job Responsibilities

• Develop and maintain IFU documents, including product illustrations, layout design, and illustrative material and copy

• Utilize existing templates in Bartender, Adobe LiveCycle, EnLabel, and related programs to create or revise labeling artwork and content based on corporate graphic standards and procedures

• Use PLM (Windchill) for document control processes and routing all work for approval

• Perform prepress activities to prepare labeling artwork files for accurate, first-article output

• Prepare and route labeling packages for first article and final approvals

• Proofread labeling artwork using measurement and inspection tools (e.g., rulers, barcode scanners) and related documentation

• Review and update documentation to ensure proper revision control and storage of all labeling

• Collaborate with manufacturing, engineering, regulatory, legal, product development, and marketing to complete labeling and artwork assignments

• Work with cross-functional teams to address NCRs and CAPAs, investigate and analyze issues, identify root causes, and contribute to long-term solutions

• Maintain and follow compliance and quality system requirements, ensuring documentation reflects continuous improvement activities and new or improved processes

Pay: 34-45

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client.

Pay Details: $34.00 to $45.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.