Joining Integra LifeSciences is a chance to do important work that creates change and shapes the future of healthcare. The Director, Post Market Quality will lead a cross-functional team and partner with global leaders to develop processes that result in attaining the company's improvement objectives and growth strategies across Integra manufacturing and design facilities.
Requirements
- Bachelor's degree in engineering, life sciences, quality, or related scientific field
- 15+ years in medical device quality, with 10+ years focused on complaints, vigilance/reportability, field actions/recalls, or PMS; 8+ years people leadership
- US FDA complaint handling & medical device reporting (21 CFR 803, 820)
- EU MDR post-market vigilance (Articles 87â92) and PMS integration
- MDSAP frameworks with working knowledge across Australia (TGA), Brazil (ANVISA), Canada (SOR/98â282), Japan (PMDA/MHLW), and US (FDA)
- ISO 13485:2016 and ISO 14971:2019
Benefits
- Medical, dental, vision, life insurance
- Short- and long-term disability
- Business accident insurance
- Group legal insurance
- Savings plan (401(k))