Post Market Document & Project Coordinator (Hybrid - Acton, MA.)

This Post Market Document & Project Coordinator at Insulet is responsible for quality activities to ensure current process requirements are met. Interfaces with other Insulet departments (e.g. Operations, and Information Technology, Engineering, and Regulatory Affairs) as well as other external parties on issues related to product monitoring. Effectively processing documents, coordinating project deliverables, assessing schedule risks and addressing any conflicting requirements are resolved.Responsibilities:

• Collaborate with staff to review, approve and overall ensure compliance within QMS documents.
• Responsible for maintaining and updating departmental documents
• Leads projects-creation of schedule, deliverables in collaboration with stakeholders
• Prepares and coordinates monthly project metrics -Quality Events, CAPA, deviations
• Works on Global Product Monitoring continuous improvement process globally
• Coordinates GPM activities required to support new product launches
• Participates in Global Product Monitoring risk management activities
  Perform other duties as requested

Minimum Requirements:

• Bachelor’s degree.
• A minimum of 3 years’ experience in a professional role within the medical technology, life sciences, or healthcare setting.

Preferred Skills and Competencies:

• Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820), ISO 13485 Medical devices – Quality management systems, and ISO 14971 – Application of risk management to medical devices.
• At least 3 years experience in a technical and/or quality/compliance discipline/regulated industry.
• Demonstrated experience organizing and maintaining large documentation sets.
• Ability to coordinate, maintain, manage and follow up with task owners to close out open items.
• Effective verbal and technical writing skills. Ability to communicate at multiple levels of an organization.
• Knowledge of Microsoft Office programs (e.g. Word, Excel, and PowerPoint)
• Ability to organize and judge priorities.
• Strong attention to detail with excellent grammatical, editorial, and proofreading skills.
• Project management skills: timelines, ownership, drive accountability, etc.
• Experience leading/managing improvement projects.
• Ability to problem solve / conduct root cause investigations.
• Periodic travel may be required

NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 1x/week; may work remotely other days). #LI-Hybrid 

Additional Information:

The US base salary range for this full-time position is $69,525.00 - $104,287.50. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.