We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.
Job Details
Responsibilities/Essential Duties
- Support the labeling development of all locations in Haemonetics, CMOs, and OEMs.
- Understand Global Regulatory requirements of Medical Devices or Pharma Labeling.
- Provide technical expertise for the Labeling Platform, where necessary.
- Provide follow-up with SMEs and stakeholders to ensure timely input, change management, and approvals.
- Control label documentation, markup, and proofread label text, for distribution to cross-functional partners and/or third-party vendors.
- Write clear manufacturing or process steps, and coordinate its verification and training.
- Create and maintain specifications of products and components by using CAD software (AutoCAD/SolidWorks).
- Submit labeling-related workflows in Agile PLM.
- Issue label part numbers and related items, and maintain accurate change control documentation.
- Lead and/or oversee label projects in compliance with regulatory, commercial, and R&D guidelines.
- Lead project implementations ensuring projects’ stakeholders and manufacuring expectations are aligned (i.e. cut in times, scrap, reworks, & etc.).
- Meet with Manager to discuss plans of action and implement action items based on decisions made or written SOPs.
- Perform duties that are to support labeling project goals and/or assignments from Manager.
- Project planning – coordinate with Manager and cross-functional partners to ensure milestones are established, achievable, and completed at or ahead of communicated deadlines.
- Represent the department in meetings and interacts with various departments, to complete projects in a timely manner.
- Review and update Standard Operating Procedures (SOPs) and Work Instructions (WIs).
- Update labeling SOPs and WIs, as needed, and write label status reports.
Requirements: -
- Degree in Engineering, Science, Quality, Manufacturing, or related field.
- CAD software experience is a must.
- Experience in labeling, documentation, quality, or manufacturing support is an added advantage.
- Expertise with Robar or other Enterprise Labeling System, preferred.
- Basic understanding of labeling processes and quality requirements.
- Familiar with artwork formatting and documentation control.
- Familiarity with manufacturing, production and quality assurance environments is required.
- Demonstrates a high commitment to quality.
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