The Quality Project Management is responsible for leading and delivering a portfolio of projects that initially focus on Quality Management System (QMS) effectiveness and compliance with ISO 9001, FSSC 22000, and ISO 13485, and progressively expands into broader cross-functional initiatives supporting business priorities. This role establishes disciplined project planning, governance, risk management, and stakeholder communication to ensure projects are executed on time, within scope, and aligned to internal procedures and customer expectations. The Project Manager partners with Quality, Operations, Engineering, Supply Chain, and other functions to drive sustainable improvements, audit readiness, CAPA effectiveness, and operational excellence. With a strong emphasis on compliance, transparency, and structured execution, this position is critical to delivering measurable results while maintaining a culture of safety, quality, and continuous improvement.
- Act as a role model and ensure safety is built into project execution, meeting cadence, and work processes.
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Lead QMS and compliance-related projects aligned to ISO 9001, FSSC 22000, and ISO 13485, including planning, scheduling, resource coordination, and delivery tracking.
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Partner with Quality leadership to prioritize and maintain a QMS improvement roadmap (e.g., document control, internal audits, CAPA, training, management review inputs).
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Facilitate CAPA-related project execution by coordinating actions, owners, due dates, effectiveness checks, and escalation when milestones are at risk.
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Coordinate internal audit schedules and readiness activities (as applicable), including action tracking, evidence collection support, and closure monitoring.
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Drive structured problem-solving and risk-based thinking on project issues to ensure solutions are sustainable and aligned to system requirements.
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- Develop and maintain project documentation such as charters, schedules, risk logs, assumption logs, action logs, communication plans, and closure/lessons learned.
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Establish project governance and provide consistent reporting to leadership and stakeholders.
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Monitor project performance and escalate risks and opporutnities
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As the role expands, lead cross-functional initiatives beyond Quality (e.g., manufacturing readiness, process changes, supplier initiatives, training rollouts, and operational performance projects).
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Coordinate change implementation with impacted departments to ensure alignment, documentation updates, training completion, and effective adoption
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Partner with Supply Chain and Operations to align material, supplier, and production readiness activities to project timelines.
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Drive continuous improvement by standardizing best practices (templates, playbooks, meeting discipline, reporting cadence) and tracking outcomes.
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Other duties as required.
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Bachelor’s degree in Business, Engineering, Quality, Life Sciences, Operations, or a related field (or equivalent experience).
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3–5 years of project management experience in manufacturing, quality systems, medical device/regulated, food safety, or similarly structured environments preferred.
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Working knowledge of QMS concepts aligned to ISO 9001, FSSC 22000, and ISO 13485, including documentation rigor, internal audits, CAPA, training, and risk-based thinking.
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Strong project management fundamentals: scope, schedule, resource planning, risk management, stakeholder management, and disciplined action tracking.
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Demonstrated ability to lead cross-functional teams, influence without authority, and maintain accountability across stakeholders.
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Proficient with common project and collaboration tools (e.g., Microsoft Office, Teams, SharePoint; scheduling tools preferred).
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Strong analytical/problem-solving skills and ability to remove barriers and drive closure.
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Excellent written and verbal communication skills; able to provide clear status updates and executive-ready reporting.
