Quality Assurance Validation Specialist
2 weeks ago
- Be a vital member of a team that collaborates closely with leadership.
- Contribute to the growth of a site with a strong reputation in the medical device industry.
Our client is a prominent global manufacturer specializing in the assembly of medical devices. With over 60 years of industry experience and a presence in more than 10 locations worldwide, they are poised for significant growth in the near future.
Position Overview
The primary responsibilities of the Quality Validation Engineer include:
Development and Execution of Validation Protocols
- Create and implement comprehensive validation master plans, protocols, and reports for various equipment, processes, and software.
- Conduct Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for both new and existing equipment.
- Ensure that all validation activities adhere to FDA, ISO 13485, and other pertinent regulatory standards.
- Perform risk assessments utilizing methodologies such as FMEA (Failure Modes and Effects Analysis) to identify and mitigate potential hazards.
- Work collaboratively with cross-functional teams to devise and implement effective risk mitigation strategies.
- Identify and pursue opportunities for process enhancements to improve efficiency and product quality.
- Remain informed about industry trends, regulatory updates, and best practices in validation engineering.
Qualified candidates will be contacted promptly and provided with a detailed job description for the position.
Ideal Candidate Profile
The successful Quality Validation Engineer will possess:
Required Skills:
- Experience with validation protocols (IQ, OQ, PQ).
- Background in Root Cause Analysis.
- Strong independent time management and communication abilities.
- Experience in metrology, particularly with Calypso (Zeiss CMM software).
- Familiarity with Minitab.
- Exposure to injection molding processes.
The organization provides:
- Competitive base salary.
- Bonus potential.
- Comprehensive benefits package.
- Opportunities for career advancement within the company.
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