Arni Medica® is a global leader in medical devices and contract manufacturing, committed to enhancing patient outcomes with innovative therapies and devices. Headquartered in New Jersey, USA, Arni Medica also operates out of Hyderabad, India, focusing on providing solutions that address the complete patient journey—from diagnosis to life-sustaining and life-saving devices. With its rapid growth, the company is at the forefront of medical device development, ensuring strict adherence to regulatory and quality standards.
Job Responsibilities:
As a Sr. Executive Quality Assurance, you will oversee and manage the quality assurance (QA) processes within the medical device production environment. Key responsibilities include:
- Leading Quality System (QS) activities and ensuring regulatory compliance.
- Managing the internal audit program and leading third-party audits.
- Overseeing the Quality Management System (QMS) activities and ensuring proper documentation.
- Authoring and reviewing QS documents to ensure compliance with QSR, ISO, and EN standards.
- Ensuring effective post-market surveillance and handling of complaints.
- Leading continuous improvement initiatives within the quality system.
- Preparing quality investigation reports, including corrective and preventive actions.
- Managing document and record control according to standards.
Qualifications:
To be considered for this role, you must have:
- Minimum 2 years of experience in quality management systems, specifically ISO 13485:2016.
- Expertise in medical device regulations and standards like FDA QSR, ISO 13485, etc.
- Experience with Good Documentation Practices (GDP).
- Proven auditing experience and the ability to lead quality processes independently.
- Certified as an ISO 13485:2016 Lead Auditor.
Skills Required:
- In-depth knowledge of medical device regulations (ISO 13485, FDA QSR).
- Strong organizational skills and attention to detail in documentation.
- Ability to work independently with minimal supervision.
- Excellent communication and interpersonal skills for cross-team collaboration.
Desired Skills (Additional Advantage):
- Training in 21 CFR 820 requirements and ISO 14971 risk management standards.
- Critical thinking and problem-solving skills.
- Strong writing skills for reporting and documentation.
