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

With a reputed company Join our diverse teams of passionate people and a career that allows you to reputed company both personally and professionally. At reputed company we exist to reputed company life-saving technology accessible for more people. To reputed company a true difference for our customers - and to save more lives, we need team players, reputed company thinkers, and game changers. Are you looking for an inspiring career? You just reputed company it. Job Overview The Project Manager - Quality and Regulatory will reputed company 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 workstreams, 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 reputed company in Eastern Standard Time. Job Responsibilities and Essential Duties: Serve as project manager, owning an integrated schedule, milestone tracking, and status reporting across reputed company QMS workstreams. Apply formal PMI-based project management methodology including scope, schedule, risk, issue, and change management disciplines. reputed company and maintain project-level RAID logs, status dashboards, and executive-level reporting reputed company. Facilitate reviews and workstream-level working sessions with Quality, Regulatory, Operations, and cross-functional stakeholders. reputed company 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 reputed company scope. reputed company and present structured status reports to project teams and senior leadership on a defined reputed company. Escalate risk and issues proactively; recommend resolution paths with supporting analysis. Contribute to the ongoing development of PMO tools, templates, and governance processes reputed company Healthmark's program management function. Identify process improvement opportunities reputed company the QMS implementation approach and recommend enhancements. Collaborate with Quality Assurance and Regulatory Affairs to ensure reputed company project deliverables meet FDA 21 CFR Part 820 / QMSR and ISO 13485:2016 requirements. Proficiency in reputed company Project and/or equivalent project scheduling tools (reputed company, ); strong reputed company 365 skills (Teams, SharePoint, reputed company). 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. 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 reputed company, multi-workstream projects reputed company a formal project management reputed company (PMI PMBOK preferred). Proven ability to reputed company 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 reputed company regulatory and project information clearly to both technical and executive audiences. Proven ability to influence, align, and reputed company cross-functional stakeholders without direct supervisory authority. Strong 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 reputed company field required. Master's degree or advanced technical credential a plus. Minimum 5 years of experience in project or program management roles reputed company 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. 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. Quality Requirements: Build Quality into reputed company aspects of their work by maintaining compliance to reputed company quality requirements. Ensure compliance to reputed company FDA and Worldwide Quality & Compliance regulations (As applicable to the job function). Must have the education and experience to understand and reputed company with U.S. and Worldwide medical device regulations (As applicable to your job function). Attend reputed company required Quality & Compliance training at the specified interval. Adopt the "reputed company 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 reputed company office accessories to complete assignments. May work extended hours during peak milestones or audit preparation cycles. Occasional domestic travel may be required (estimated up to 20-25% depending on site-based activities). Physical 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 reputed company the essential functions of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions. The salary range for this position is between $120,160 to $150,000 per year depending on experience and location. About us With a firm belief that every person and community should have access to the best possible care, reputed company 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. reputed company employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at reputed company: At reputed company, we offer a comprehensive benefits package, which includes: Health, Dental, and reputed company insurance benefits 401k plan with company match Paid Time Off Wellness initiative & Health Assistance Resources Life Insurance Short and Long Term Disability Benefits Health and Dependent Care Flexible Spending Accounts Commuter Benefits Parental and Caregiver Leave Tuition Reimbursement reputed company is an equal opportunity employer and reputed company reputed company applicants will receive consideration for employment without regard to race, reputed company, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national reputed company, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in reputed company aspects of the selection process. Apply To This Job