Validation Engineer-Medical Device

We're Hiring: Validation Engineer – Medical Device Industry!

We are looking for an experienced Validation Engineer to join our team and support validation activities within a regulated medical device manufacturing environment.

⏳ Employment Type: [Contract / Full-Time]

Key Responsibilities:

• Develop and execute validation protocols, including IQ, OQ, and PQ.
• Support process validation, equipment qualification, and manufacturing validation activities.
• Prepare and maintain validation plans, protocols, and summary reports.
• Perform risk assessments, root cause analysis, and validation-related investigations.
• Support process improvements and continuous improvement initiatives.
• Ensure compliance with FDA regulations, ISO 13485, and GMP requirements.
• Collaborate with Quality, Manufacturing, and Engineering teams.

Required Skills:

• Medical Device Industry experience.
• Hands-on experience with IQ/OQ/PQ and Process Validation.
• Knowledge of FDA 21 CFR Part 820 and ISO 13485.
• Experience with PFMEA, Risk Assessment, and Validation Documentation.
• Strong understanding of GMP and Quality Management Systems.

Thanks

Suchi

Vastek Group

Vastek Inc is managed by a group of dedicated professionals having rich experience of over years in Healthcare, IT consulting and staffing. We are a certified minority owned, Small business company head quartered out of San Diego, with coverage all across United States, Canada, Mexico, Italy and India. We specialize in Engineering, Validation, Regulatory, IT and NON-IT related areas primarily focused on Pharmaceutical / Life Sciences and Medical device companies.