Remote Project Manager, QMS & Regulatory Excellence

Getinge; Indianapolis (IN); Remote; USD 120,160 - 150,000; Full time

Benefits offered by this job

Health, Dental, and Vision insurance benefits

401k plan with company match

Paid Time Off

Tuition Reimbursement

Job summary

Getinge seeks a Project Manager - Quality and Regulatory in Indianapolis, IN to lead QMS enhancement projects. This role involves managing project execution among various teams to ensure compliance with FDA and ISO standards. The ideal candidate will have at least 5 years of experience in project management within the medical device industry.

This position allows for remote work with candidates required to reside in Eastern Standard Time. Benefits include health insurance, 401k, and paid time off.

Qualifications

• 5+ years of experience in project management roles within the medical device industry.
• 3+ years of hands-on experience managing QMS projects under regulatory guidelines.
• PMP certification preferred.

Responsibilities

• Lead QMS projects and maintain integrated schedules.
• Develop project-level RAID logs and status reports.
• Facilitate project coordination across QMS enhancement areas.

Skills

Project Management

FDA 21 CFR Part 820

ISO 13485:2016

Microsoft Project

Cross-functional Coordination

Risk Management

Education

Bachelor’s degree in engineering or related field

Master’s degree or advanced technical credential

Tools

Smartsheet

Monday.com

Job description

Getinge seeks a Project Manager - Quality and Regulatory in Indianapolis, IN to lead QMS enhancement projects. This role involves managing project execution among various teams to ensure compliance with FDA and ISO standards. The ideal candidate will have at least 5 years of experience in project management within the medical device industry.

This position allows for remote work with candidates required to reside in Eastern Standard Time. Benefits include health insurance, 401k, and paid time off.