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

Getinge is a company dedicated to making life-saving technology accessible for more people. They are seeking a Project Manager to lead and coordinate Quality Management System enhancement initiatives, ensuring effective communication and delivery of project milestones across cross-functional teams.

Responsibilities:

• Serve as project manager, owning an integrated schedule, milestone tracking, and status reporting across all QMS workstreams
• 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

Requirements:

• Bachelor's degree in engineering, Life Sciences, Quality, Business Administration, or a related field required
• Minimum 5 years of experience in project or program management roles within the medical device industry
• Minimum 3 years of direct, hands-on experience implementing or managing QMS projects under FDA 21 CFR Part 820 and/or ISO 13485 in a regulated medical device environment
• 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
• Demonstrated experience leading complex, multi-workstream projects within a formal project management framework (PMI PMBOK preferred)
• Proven ability to develop and manage integrated project schedules, RAID logs, status reports, and steering committee materials
• Experience managing cross-functional teams in a matrixed organizational environment without direct line authority
• Excellent written and verbal communication skills; ability to present complex regulatory and project information clearly to both technical and executive audiences
• Proven ability to influence, align, and lead cross-functional stakeholders without direct supervisory authority
• Strong organizational skills; detail-oriented with a track record of delivering on schedule in regulated environments
• Master's degree or advanced technical credential a plus
• Experience in supporting or leading QMS projects for companies undergoing FDA Class I and/or Class II classification transitions or regulatory remediation projects is strongly preferred
• PMP (Project Management Professional) certification is highly desired