SENIOR VALIDATION QUALITY ENGINEER:

On behalf of our Medical Device client, Procom is searching for a Senior Validation Quality Engineer for a 6-month role. This position is an onsite position at our client’s Sturtevant, Wisconsin office.

SENIOR VALIDATION QUALITY ENGINEER - JOB DESCRIPTION:

The Senior Validation Quality Engineer will provide validation, engineering, and technical support for facilities supporting Manufacturing and Distribution. This role will coordinate and execute product and process validations, oversee equipment and system qualifications, and ensure compliance with Quality Standards and Regulations.

SENIOR VALIDATION QUALITY ENGINEER - MANDATORY SKILLS:

• Bachelor’s degree in Physical Science or Engineering, or equivalent experience
• 3–5 years of experience in Medical Device or Pharmaceutical industry
• 3–5 years in a Quality role
• 3–5 years in a Validation Engineering role
• Strong knowledge of medical device/pharmaceutical quality requirements
• Proficiency in Microsoft Word, Excel, PowerPoint, Visio, Adobe, and Quality System Management Software
• Experience with NCR/CAPA processes and statistical data analysis

SENIOR VALIDATION QUALITY ENGINEER – NICE-TO-HAVE SKILLS:

• 3+ years working with electromechanical devices
• ASQ Certification as a Quality Engineer

• Oversee product, process, and test method validation and re-validation activities
• Lead Installation, Operational, and Performance Qualification (IQ/OQ/PQ) for equipment, systems, and computerized processes
• Assist Manufacturing and R&D in developing and validating new products and processes
• Review and approve operating procedures and specifications
• Support NCR and CAPA activities, capturing and analyzing data for improvement initiatives
• Provide leadership in data analysis and promote quality improvement processes
• Drive supplier quality improvements and compliance initiatives in line with cGMP standards
• Support training programs and deliver assigned training tasks
• Participate in regulatory inspections and internal/vendor audits
• Ensure compliance with FDA, ISO 13485, GMP, and other medical device regulations
• Provide support to Quality Management and perform other duties as assigned