The Global Vice President QARA Compliance provides assurance and manages all aspects of Regulatory Compliance. The focus will be over the implementation of the Global Quality Systems Processes, compliance with FDA CFR, Part 820, Quality System Regulation and ISO 13485 and all other applicable global regulatory requirements.
Requirements
- Minimum 15 years of experience in Audit Assurance within the medical device industry with 7 years of specific leadership and/or management experience.
- BA/BS degree or equivalent.
- Ability to work effectively in a fast paced and dynamic environment.
- Leadership and interpersonal skills to develop and manage good working relationships with internal departments (R&D, Manufacturing, Supply Chain, Quality etc).
- Strong analytical skills, and the ability to analyze and identify trends and root causes.
- Very strong risk/auditor skills – critical to evaluate remediation of issues and management’s action plans.
- Excellent interpersonal and leadership skills with diverse cultural approach.
- A self-starter motivated and able to positively motivate others. Demonstrates the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside Olympus.
- Focused, target driven with a positive, can-do attitude and a desire to improve patient experience as well as company performance.
- Excellent writing and verbal skills.
Benefits
- Competitive salaries, annual bonus and 401(k) with company match
- Comprehensive medical, dental, vision coverage effective on start date
- 24/7 Employee Assistance Program
- Free live and on-demand Wellbeing Programs
- Generous Paid Vacation and Sick Time
- Paid Parental Leave and Adoption Assistance
- 12 Paid Holidays
- On-Site Child Daycare, Café, Fitness Center