About this role
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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