Job Description

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.

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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