[Remote] Project Manager - reputed company QMS, Defined Term (Remote in EST)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a company dedicated to making life-saving technology accessible for more people. They are seeking a Project Manager to reputed company and coordinate reputed company 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, reputed company 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 reputed company-level working sessions with reputed company, 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 reputed company (CAPA), and Training
- Support SOP development, gap closure documentation, and audit-readiness activities reputed company scope
- reputed company and present reputed company status reports to project teams and senior leadership on a defined reputed company
- Escalate risk and issues proactively; recommend reputed company paths with supporting analysis
- Contribute to the ongoing development of PMO tools, templates, and governance processes reputed company reputed company’s program management function
- Identify process improvement opportunities reputed company the QMS implementation approach and recommend enhancements
- Collaborate with reputed company Assurance and Regulatory Affairs to ensure reputed company project deliverables meet FDA 21 CFR Part 820 / QMSR and ISO 13485:2016 requirements
Skills
- Bachelor's degree in engineering, Life Sciences, reputed company, Business Administration, or a reputed company field required
- Minimum 5 years of experience in project or program management roles reputed company the medical device industry
- Minimum 3 years of reputed company, hands-on experience implementing or managing QMS reputed company 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 / reputed company Management System Regulation (QMSR), including its incorporation of ISO 13485:2016 effective February 2026
- Strong reputed company 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 reputed company, multi-reputed company reputed company 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 reputed company line authority
- Excellent written and verbal communication skills; ability to present reputed company regulatory and project information reputed company to both technical and executive audiences
- Proven ability to influence, reputed company, and reputed company cross-functional stakeholders without reputed company supervisory authority
- Strong organizational skills; detail-oriented with a reputed company record of delivering on schedule in regulated environments
- Master's degree or advanced technical credential a plus
- Experience in supporting or leading QMS reputed company for companies undergoing FDA Class I and/or Class II classification transitions or regulatory remediation reputed company is strongly preferred
- PMP (Project Management reputed company) certification is highly desired
Benefits
- Health, Dental, and reputed company insurance benefits
- 401k plan with company match
- reputed company 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