Project Manager - Healthmark QMS, Defined Term; Remote in EST

Project Manager - Healthmark QMS, Defined Term (Remote in EST)

Date:
Jun 25, 2026

Location:

Lansing, MI, US Wayne, NJ, US Baltimore, MD, US Charlotte, NC, US Hartford, CT, US Miami, FL, US Atlanta, GA, US New York City, NY, US Indianapolis, IN, US Montpelier, VT, US Dover, DE, US Richmond, VA, US Boston, MA, US Nashua, NH, US Providence, RI, US Augusta, ME, US Charleston, WV, US Philadelphia, PA, US Columbus, OH, US Company:
Healthmark Industries Co., Inc. Remote Work: 5 days at home (fully remote) Salary Range: $120,160 to $150,000 /annually With a passion for life join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

The Project Manager – Quality and Regulatory will lead and coordinate projects aimed at Quality Management System (QMS) enhancement initiatives. The project manager will serve as the primary driver of project(s) execution across a group of QMS work streams, coordinating cross-functional teams and ensuring delivery against defined milestones. Key deliverables include the development of project timelines, project team assembly, managing the schedule and maintaining effective communication through the project.

This position is defined term for approximately 12 months. While the role is remote, candidates should reside in Eastern Standard Time.

• Serve as project manager, owning an integrated schedule, milestone tracking, and status reporting across all QMS work streams.
• Apply formal PMI-based project management methodology including scope, schedule, risk, issue, and change management disciplines.
• Develop and maintain project-level RAID logs, status dashboards, and executive-level reporting cadence.
• Facilitate reviews and workstream-level working sessions with Quality, Regulatory, Operations, and cross-functional stakeholders.
• Lead project coordination across the following QMS enhancement areas:
  Product Development Process, Receiving Inspection, Complaints & Vigilance, Validation, Device History Records (DHRs), Inspection & In-Process Controls, Corrective and Preventive Action (CAPA), and Training.
• Support SOP development, gap closure documentation, and audit-readiness activities within scope.
• Develop and present structured status reports to project teams and senior leadership on a defined cadence.
• Escalate risk and issues proactively; recommend resolution paths with supporting analysis.
• Contribute to the ongoing development of PMO tools, templates, and governance processes within Healthmark's program management function.
• Identify process improvement opportunities within the QMS implementation approach and recommend enhancements.
• Collaborate with Quality Assurance and Regulatory Affairs to ensure all project deliverables meet FDA 21 CFR Part 820 / QMSR and ISO 13485:2016 requirements.
• Proficiency in Microsoft Project and/or equivalent project scheduling tools (Smartsheet, ); strong Microsoft 365 skills (Teams, SharePoint, Excel).

Expert-level working knowledge of FDA 21 CFR Part 820 / Quality Management System Regulation (QMSR), including its incorporation of ISO 13485:2016 effective February 2026. Strong applied understanding of ISO 13485:2016 QMS requirements throughout the device lifecycle. Demonstrated hands-on experience with the following QMS process areas:
Product Development Process / Design Controls, Receiving Inspection, Complaints & Vigilance / MDR reporting, Validation (IQ/OQ/PQ), Device History Records, Inspection and In-Process Controls, CAPA, and Training. Familiarity with ISO 14971 risk management principles and FDA 510(k) / Class II submission processes is advantageous. Demonstrated experience leading complex, multi-workstream projects within a formal project management framework (PMI PMBOK preferred). Proven ability to develop and manage integrated project…