Role OverviewThe Project Manager – Quality and Regulatory will lead 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.
What You Will Do
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.
Why It Might Be a Fit
This position is ideal for a project manager with experience in the medical device industry, specifically in QMS projects under FDA 21 CFR Part 820 and/or ISO 13485. The candidate should have strong organizational skills, excellent written and verbal communication skills, and the ability to present complex regulatory and project information clearly to both technical and executive audiences.
Requirements
- Bachelor’s degree in engineering, Life Sciences, Quality, Business Administration, or a related field
- 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
- PMP (Project Management Professional) certification is highly desired
Benefits
- Health, Dental, and Vision 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
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