This role is responsible for the development, validation, and implementation of label designs for finished medical devices developed by Nextern. Labeling Specialists are members of product development teams, utilizing their expertise to develop label designs aligning with device risk management files and relevant regulatory requirements, identify label printing process controls to ensure printed content is accurate, and ultimately transfer into commercial manufacturing. This role is also responsible for sustaining activities related to labeling including, but not limited to: changes and impact assessments, global regulatory compliance, nonconformances and complaints, and process improvement. All functions are responsible for compliance with the Quality System, regulations and standards, continuous improvement, and as needed, professional interaction with Nextern Customers.
RESPONSIBILITIES- Development project team member accountable for label design across several programs simultaneously
- Coordinate and execute, as necessary, label verification activities
- Support label print station qualifications
- Review, assess, and approve design and process changes to existing package and label designs or processes
- Lead and coordinate labeling activities for new product launches, market expansions, and regulatory updates across departments
- Liaison to label raw material and equipment suppliers
- Serve as organizational SME for labeling requirements, including audits
- Draft/own labeling processes, guidelines, templates, and forms within the Quality System
- Develop and validate, as necessary, label print artwork files and printing process
- Create and maintain up-to-date product Design History Files (DHF)
- Interface between manufacturing/PLM and supply chain/ERP ensuring batch specific (i.e. lot/serial number) information is accurate across systems
RequirementsQUALIFICATIONSRequired:- Degree in graphic design, communication, business, or equivalent
- 3+ years of experience in a Labeling Specialist role
- Experience working in quality systems as defined in 21 CFR 820 and ISO 13485.
- Understanding of ISO 14971 and application of risk management to product development and processes
- Familiarity with medical device industry specific labeling requirements
- Understanding of configuration management in relation to variable data and label templates
- Familiarity with harmonized and recognized test standards for labeling
- Experience using barcoding systems (e.g. GS1, HIBC-128)
- Proficient in label design and management software (e.g. BarTender, GSI Data Hub)
- High attention to detail, organization, and accuracy
- Instinctual capability for creative thinking and proposing novel solutions
- Strong ability to communicate (written and verbally) within and across disciplines and organization structures.
- Demonstrated use of quality tools and methodologies (e.g. nonconformance, CAPAs, root cause analysis, etc..).
- Experience with Product Lifecycle Management (PLM) software (e.g Windchill, Agile, Propel)
- Experience with Enterprise Resource Planning (ERP) software (e.g. Epicor, Net Suite)
- Intermediate to advanced proficiency with MS Office Suit (Word, Excel, PowerPoint, Project, Outlook).
Preferred:- Global experience preferred
Salary range: $70,000 to $100,000 per year depending on skills and experience
Benefits- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan with Company Match
- Paid Time Off, Personal Days, AND Birthday Holiday!
- Lifetime Membership Subsidy and Wellness Resources
- Life Insurance (Basic, Voluntary & AD&D)
- Family Leave (Maternity, Paternity)
- Short-Term & Long-Term Disability
- Taco Thursdays!!!
