Manufacturing Validation Specialist
1 week ago
Job Title: Manufacturing Validation Engineer
Job Summary:
We are seeking a highly skilled Manufacturing Validation Engineer to join our team at SysMind Tech. As a key member of our quality assurance team, you will be responsible for ensuring the quality and reliability of our medical devices.
Key Responsibilities:
- Support medical device manufacturing processes and ensure compliance with regulatory requirements.
- Develop and implement process validation plans, including process characterization, equipment IQ/OQ, process OQ, and PQ validation.
- Lead and prioritize multiple medium-complexity project assignments and complete work in a timely manner.
- Collaborate with cross-functional teams to identify and resolve technical and process issues.
- Develop and maintain quality control procedures, including change management, nonconformance reports, and corrective and preventive action.
Requirements:
- Experience in medical device manufacturing and validation.
- Strong knowledge of design control and cGMP requirements for medical device manufacturing.
- Ability to read and understand engineering drawings.
- Proficiency in statistical process control concepts, process development, and CNC programming terminology.
- Excellent communication and problem-solving skills.
What We Offer:
At SysMind Tech, we offer a dynamic and challenging work environment, competitive compensation, and opportunities for professional growth and development.
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