Compunnel, Inc., founded in 1994 and headquartered in New Jersey, is at the forefront of providing customized workforce and digital transformation solutions, enhancing the total experience for our valued business allies. Our approach integrates innovative technologies with a human-centric dialogue, exceeding the needs of our customers, employees, partners, and key growth contributors and delivering exceptional value.  

With a strategic presence across the United States through over 30 local service delivery centers and global support from our centers in Canada, India, and the UK, Compunnel proudly serves over 200 clients, including 23% of Fortune-listed enterprises. Our expertise is trusted by various clients, from global corporations to various federal, state, and local agencies seeking premier talent solutions.  

An 12-time honoree by Inc. 5000 as one of the Fastest-Growing Private Companies in the US, Compunnel facilitates businesses in multiple sectors to secure top-tier talent and cutting-edge technology solutions. We specialize in Software Development, Cloud Services, Data Analytics, AI & Machine Learning, Cybersecurity, and  Recruitment Solutions in IT, Non IT & for Public Sector. Our AI-powered, intelligent solutions are at the core of our digital offerings, driving smarter decision-making and empowering organizations to bridge the gap between their current and desired states with precision, speed, and  a measured approach. For over three decades, we have been the leading choice of more than 23% of Fortune 500 companies for their technology and talent needs.   

As a recognized Minority Business in the US and Canada, we champion diversity and inclusivity, ensuring equal opportunities for talent from diverse backgrounds. Our robust partnerships with technology leaders like AWS, Microsoft, UiPath, and Google Cloud reflect our commitment to pioneering AI-driven innovations and establishing centers of excellence for our Fortune 500 clients worldwide.

Industry: IT Services and IT Consulting
Company Size: 5,001-10,000 employees

Compunnel Inc.

Savvy Admin PROD

**Key Responsibilities: **

- Develop, execute, and document validation protocols including:

- Installation Qualification (IQ) / Operational Qualification (OQ)

- Performance Qualification (PQ)

- Test Method Validation (TMV)

- Analytical Qualification (AQ)

- Spreadsheet validation activities

- Support validation activities related to process validation reagents used in manufacturing.

- Design, maintain, and improve quality management systems (QMS), ensuring alignment with regulatory requirements.

- Monitor, audit, and enhance processes, procedures, and system automation to maintain compliance.

- Collaborate with cross-functional teams, including Manufacturing, R&D, and Quality to ensure validation and quality objectives are met.

- Participate in internal and external audits and support regulatory inspections.

**Required Qualifications: **

- Minimum 5+ years of experience in the medical device or regulated manufacturing industry.

- Strong knowledge of regulatory standards such as:

- **21 CFR Part 820 **

- **ISO 13485 **

- Proficiency in Microsoft Excel and working knowledge of computer systems and basic programming concepts.

- Experience in validation documentation and execution.

Quality Assurance Engineer — SAHDC5766588

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