Job Responsibilities and Essential Duties:

Serve as project manager, owning an integrated schedule, milestone tracking, and status reporting across all QMS workstreams.\nApply formal PMI-based project management methodology including scope, schedule, risk, issue, and change management disciplines.\nDevelop and maintain project-level RAID logs, status dashboards, and executive-level reporting cadence.\nFacilitate reviews and workstream-level working sessions with Quality, Regulatory, Operations, and cross-functional stakeholders.\nLead 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.\nSupport SOP development, gap closure documentation, and audit-readiness activities within scope.\nDevelop and present structured status reports to project teams and senior leadership on a defined cadence.\nEscalate risk and issues proactively; recommend resolution paths with supporting analysis.\nContribute to the ongoing development of PMO tools, templates, and governance processes within Healthmark's program management function.\nIdentify process improvement opportunities within the QMS implementation approach and recommend enhancements.\nCollaborate with Quality Assurance and Regulatory Affairs to ensure all project deliverables meet

FDA 21 CFR

Part 820 / QMSR and

ISO 13485

2016 requirements.\nProficiency in Microsoft Project and/or equivalent project scheduling tools (Smartsheet, Monday.com); strong Microsoft 365 skills (Teams, SharePoint, Excel).

Required Knowledge, Skills and Abilities:

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.\nStrong applied understanding of

ISO 13485

2016 QMS requirements throughout the device lifecycle.\nDemonstrated 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.\nFamiliarity with

ISO 14971

risk management principles and FDA 510(k) / Class II submission processes is advantageous.\nDemonstrated experience leading complex, multi-workstream projects within a formal project management framework (PMI PMBOK preferred).\nProven ability to develop and manage integrated project schedules, RAID logs, status reports, and steering committee materials.\nExperience managing cross-functional teams in a matrixed organizational environment without direct line authority.\nExcellent written and verbal communication skills; ability to present complex regulatory and project information clearly to both technical and executive audiences.\nProven ability to influence, align, and lead cross-functional stakeholders without direct supervisory authority.\nStrong organizational skills; detail-oriented with a track record of delivering on schedule in regulated environments.

Minimum Requirements:

Bachelor's degree in engineering, Life Sciences, Quality, Business Administration, or a related field required.\nMaster's degree or advanced technical credential a plus.\nMinimum 5 years of experience in project or program management roles within the medical device industry.\nMinimum 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.\nExperience 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.\nPMP (Project Management Professional) certification is highly desired.

Quality Requirements:

Build Quality into all aspects of their work by maintaining compliance to all quality requirements. Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).\nMust have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).\nAttend all required Quality & Compliance training at the specified interval.\nAdopt the \"Beyond Compliance Quality Culture\" in the work environment; always meet and exceed requirements.

Environmental/Safety/Physical Work Conditions:

Primarily office/hybrid environment; use of computer, telephone, and related office accessories to complete assignments.\nMay work extended hours during peak milestones or audit preparation cycles.\nOccasional domestic travel may be required (estimated up to 20-25% depending on site-based activities).\nPhysical requirements: ability to sit/stand at a workstation for extended periods; occasional lifting up to 20 lbs. The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The salary range for this position is between $120,160 to $150,000 per year depending on experience and location. #LI-MV1 About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at

Getinge:

At Getinge, we offer a comprehensive benefits package, which includes: Health, Dental, and Vision insurance benefits\n401k plan with company match\nPaid Time Off\nWellness initiative & Health Assistance Resources\nLife Insurance\nShort and Long Term Disability Benefits\nHealth and Dependent Care Flexible Spending Accounts\nCommuter Benefits\nParental and Caregiver Leave\nTuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.

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