CAPA Facilitator
1 maand geleden
As a CAPA Facilitator at Amaris Consulting, you will play a pivotal role in supporting the Corrective and Preventive Action (CAPA) process. From identifying issues to ensuring the quality of CAPA record content, you will actively contribute to continuous improvement initiatives. Your responsibilities encompass facilitating CAPA investigations, assisting CAPA Owners, leading root cause analysis, and guiding cross-functional teams.
Responsibilities:
- Assist in CAPA activities, including assessing investigations and corrective actions.
- Facilitate CAPA investigations from issue identification to solution implementation.
- Support CAPA Owners in resource commitment, meeting scheduling, and adhering to project timelines.
- Mentor cross-functional teams in root cause analysis techniques and quality monitoring.
- Present CAPAs during audits and CAPA Review Board meetings.
- Collaborate with the Quality & Regulatory organization, specifically supporting Image Guided Therapy Systems.
Requirements:
- Hold a Bachelor's degree in Engineering or a related field; advanced degrees are advantageous.
- Possess 5+ years of experience in quality roles within the medical device or regulated industry.
- Familiarity with global regulations and standards, including 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001, and ISO 14971.
- Knowledge of statistical methods, quality tools, and problem-solving methodologies (e.g., 8D, DMAIC, SPC, FMEA, Control Plan, LEAN) is advantageous.
- Experience as a team facilitator or coach.
- Work experience in complex organizations with Manufacturing, R&D, and Engineering environments.
- Previous experience working in a global corporate environment.
- Fluent in English.
What we offer:
Join our dynamic team of talented people and discover a world full of growth and opportunity. Here's what we offer:- Rapid growth through a personalized career path and salary evaluation. 70% of our senior leaders started in entry-level roles.
- A competitive salary and benefits package
- Hone your skills through our catalogue of our Technology Academy, the Udemy platform, language lessons, webinars and workshops.
- Take control of your training with an annual personal budget and company-paid certifications.
- Enjoy flexible policies, remote work options, and great social benefits like transportation, help with relocation for internationals and collective health insurance.
- Take advantage of our WeCare program, which provides support to employees in critical situations.
- Unleash your full potential, both professionally and personally.
Amaris Consulting prides itself on being an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive work environment. To that end, we welcome applications from all qualified candidates, regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.
