Validation Engineer

WeCare Medical Specialty Group; Phillipston (MA); Remote; USD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking a highly motivated Remote Validation Engineer to enhance their validation processes for medical devices and software. In this pivotal role, you will be responsible for planning, executing, and documenting validation activities, ensuring compliance with regulatory standards such as FDA and ISO 13485. Your expertise will directly impact the quality and safety of healthcare solutions. Join a forward-thinking team that values innovation and offers a comprehensive benefits package, including competitive salary, medical insurance, and professional development opportunities. If you are passionate about improving patient outcomes and thrive in a remote work environment, this opportunity is perfect for you.

Benefits

Competitive salary

Medical, dental, and vision insurance

Life insurance and disability insurance

Paid time off (PTO)

401(k) plan with employer matching

Flexible work arrangements

Professional development opportunities

Qualifications

• 3+ years of experience in validation engineering in medical devices or pharmaceuticals.
• Strong understanding of validation principles (IQ, OQ, PQ) and regulatory requirements.

Responsibilities

• Plan and execute validation activities for medical devices and software.
• Maintain detailed documentation and ensure compliance with regulations.
• Provide technical support and troubleshoot validation-related issues.

Skills

Validation Engineering

Documentation Skills

Analytical Skills

Problem-Solving

Communication Skills

Education

Bachelor's degree in Engineering

Bachelor's degree in Life Sciences

Tools

Risk Management Systems

Quality Management Systems

Job description

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:

1. Validation Planning and Execution:
   1. Develop validation plans, protocols, and reports in accordance with regulatory requirements (e.g., FDA, ISO 13485).
   2. Execute validation testing, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
   3. Perform risk assessments and develop mitigation strategies.
   4. Coordinate and oversee validation activities with cross-functional teams (e.g., engineering, quality assurance, regulatory affairs).
2. Documentation and Reporting:
   1. Maintain accurate and detailed validation documentation.
   2. Generate validation reports and present findings to stakeholders.
   3. Ensure compliance with Good Documentation Practices (GDP).
   4. Manage and organize validation data and records.
3. Quality and Compliance:
   1. Ensure that validation activities comply with applicable regulations and standards.
   2. Identify and address deviations and non-conformances.
   3. Participate in internal and external audits.
   4. Contribute to the development and improvement of validation processes and procedures.
4. Technical Support:
   1. Provide technical support and guidance to team members on validation-related issues.
   2. Troubleshoot and resolve validation-related problems.
   3. Stay up-to-date with industry trends and advancements in validation methodologies.

Qualifications:

Required:

1. Bachelor's degree in Engineering, Life Sciences, or a related field.
2. Minimum of 3 years of experience in validation engineering, preferably in the medical device or pharmaceutical industry.
3. Strong understanding of validation principles and methodologies (IQ, OQ, PQ).
4. Knowledge of regulatory requirements (FDA, ISO 13485) and industry standards.
5. Experience with risk management and quality management systems.
6. Excellent documentation and reporting skills.
7. Strong analytical and problem-solving abilities.
8. Excellent communication and interpersonal skills.
9. Ability to work independently and manage time effectively in a remote environment.
10. United States Citizenship or Green Card Holder required.

Preferred:

1. Experience with software validation.
2. Experience with statistical analysis and data interpretation.
3. Certification in quality management or validation (e.g., ASQ CQA, CQE).

Benefits:

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

1. Competitive salary.
2. Medical, dental, and vision insurance.
3. Life insurance and disability insurance.
4. Paid time off (PTO) and holidays.
5. 401(k) plan with employer matching.
6. Flexible work arrangements.
7. Professional development opportunities.