Validation Engineer

WeCare Medical Specialty Group is a leading provider of innovative healthcare solutions, committed to improving patient outcomes and enhancing the healthcare experience through cutting-edge technology. We are dedicated to ensuring the quality, safety, and reliability of our products and services. We are seeking a highly motivated and detail-oriented Remote Validation Engineer to join our team and play a critical role in our validation processes.

Job Summary:

As a Remote Validation Engineer at WeCare Medical Specialty Group, you will be responsible for planning, executing, and documenting validation activities for our medical devices, software, and systems. You will ensure that our products meet regulatory requirements, industry standards, and internal quality standards. Your expertise in validation methodologies and documentation practices will be essential in maintaining the integrity and compliance of our products.

Responsibilities:

Validation Planning and Execution:

Develop validation plans, protocols, and reports in accordance with regulatory requirements (e.g., FDA, ISO 13485).

Execute validation testing, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Perform risk assessments and develop mitigation strategies.

Coordinate and oversee validation activities with cross-functional teams (e.g., engineering, quality assurance, regulatory affairs).

Documentation and Reporting:

Maintain accurate and detailed validation documentation.

Generate validation reports and present findings to stakeholders.

Ensure compliance with Good Documentation Practices (GDP).

Manage and organize validation data and records.

Quality and Compliance:

Ensure that validation activities comply with applicable regulations and standards.

Identify and address deviations and non-conformances.

Participate in internal and external audits.

Contribute to the development and improvement of validation processes and procedures.

Technical Support:

Provide technical support and guidance to team members on validation-related issues.

Troubleshoot and resolve validation-related problems.

Stay up-to-date with industry trends and advancements in validation methodologies.

Qualifications:

Required:

Bachelor's degree in Engineering, Life Sciences, or a related field.

Minimum of 3 years of experience in validation engineering, preferably in the medical device or pharmaceutical industry.

Strong understanding of validation principles and methodologies (IQ, OQ, PQ).

Knowledge of regulatory requirements (FDA, ISO 13485) and industry standards.

Experience with risk management and quality management systems.

Excellent documentation and reporting skills.

Strong analytical and problem-solving abilities.

Excellent communication and interpersonal skills.

Ability to work independently and manage time effectively in a remote environment.

United States Citizenship or Green Card Holder required.

Preferred:

Experience with software validation.

Experience with statistical analysis and data interpretation.

Certification in quality management or validation (e.g., ASQ CQA, CQE).

Benefits:

WeCare Medical Specialty Group offers a comprehensive benefits package, including:

Competitive salary.

Medical, dental, and vision insurance.

Life insurance and disability insurance.

Paid time off (PTO) and holidays.

401(k) plan with employer matching.

Flexible work arrangements.

Professional development opportunities.