Quality Assurance Validation Specialist
2 weeks ago
Position Summary: We are in search of a Quality Assurance Validation Specialist with a strong background in medical device production and GAMP 5 standards compliance.
Essential Qualifications:
- A minimum of a two-year degree is required; a Bachelor's degree in Systems Engineering, Life Sciences, Electrical/Controls Engineering, Quality Assurance, or a related discipline is preferred.
- At least one year of experience in validation activities is necessary; three or more years of experience is highly desirable.
- Proficiency in interpreting electrical and pneumatic schematic diagrams.
Desirable Skills:
- Experience with custom engineered solutions, particularly in Medical Devices or Life Sciences.
- Familiarity with GAMP 5 validation frameworks.
- Knowledge of PLC Control Systems.
- Strong debugging capabilities.
Key Responsibilities:
- Implement GAMP 5 standards throughout the machine assembly process for medical device production.
- Ensure adherence to FDA regulations and other relevant regulatory bodies.
- Willingness to travel up to 25% to client locations.
Compensation: $60.00 to $81.00 per hour
Benefits: Our associates enjoy a comprehensive benefits package that includes medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an Employee Assistance Program, commuter benefits, and a 401K plan. We offer flexible coverage options to meet individual needs. Additionally, associates may qualify for paid leave, including Paid Sick Leave and other mandated paid leave, as well as holiday pay where applicable.
Equal Opportunity Employer: We are an Equal Opportunity Employer, including Veterans and Disabled individuals.
Company Overview: Our organization specializes in custom automation projects and is a leading entity in the field of controls and robotic solutions globally. Joining our team will enhance your resume and position you as a top-performing controls engineer.
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