Website Karwell Technologies
Karwell Technologies
Company : Karwell Technologies
Roles & Responsibilities :
- Develop and execute process validation plans, protocols, and reports for new and existing manufacturing processes.
- Lead PFMEA sessions to identify and mitigate risks.
- Design and validate test methods to ensure product quality and regulatory compliance.
- Collaborate with cross-functional teams (Quality, Engineering, Manufacturing) to drive continuous improvement.
- Analyze validation data and recommend process optimizations.
- Maintain documentation in line with internal procedures and regulatory requirements.
- Write and maintain SOPs, work instructions, and process documentation for repeatable, high-quality production.
- Must-Have Qualifications :
- 10+ years of experience in process validation.
- Medical Device experience.
- Orthopedic experience preferred.
- Expertise in FMEAs and IQ, OQ, PQ validation.
- Strong understanding of regulatory compliance and quality standards.
- Self-starter with excellent problem-solving skills.
- Ability to work independently and collaboratively in a fast-paced environment.