Quality Engineer (validations)

This candidate will be responsible for process validation activities for new and existing process & provide validation support to the product development team, resolving bugs, defects, and other potential issues and ensuring that products meet customer specifications.

Duties/Responsibilities:

• Reviews design plans, process procedures, test procedures, and quality manuals to understand the scope, requirements, and function of products.
• Develops and implements Standard Operating Procedures for all processes involved in Quality Assurance.
• Conducts internal audits to ensure stringent requirements of ISO certification are met.
• Ensures products meet the organization’s and customers’ quality and product integrity requirements.
• Supports product development or operations team by providing analysis and expertise throughout the inspection process.
• Identifies root causes of problems in the production process; recommends and/or implements corrective measures.
• Analyzes data to identify trends in product quality or defects with the goal of mitigating and preventing recurrence and future defects.
• Performs other duties as assigned.
• Plan, execute, and document validation activities (e.g., equipment qualification, process validation)
• Generate protocols, reports, and related validation documentation
• Collaborate with Planning, Production, and NPI/Product Development teams
• Analyze data trends to improve product quality and process stability
• Support risk management and change control processes

Required Skills/Abilities: 

• Excellent verbal and written communication skills. 
• Excellent organizational skills and attention to detail.
• Extensive knowledge of or the ability to quickly learn the organization’s production processes.
• Excellent interpersonal skills with ability to serve as a liaison with developers, project managers, and customer support.
• Strong analytical and problem-solving skills.
• Proficient with Microsoft Office Suite or related software.

Education and Experience:

• Bachelor’s degree in engineering or related discipline required.
• Five to Seven years of related experience required.

Physical Requirements: 

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 25 pounds at times.

Job Type: Full-time

• Ability to travel: 25%

Job link: https://workforcenow.adp.com/mascsr/default/mdf/recruitment/recruitment.html?cid=166d9c28-9f75-40d8-8db1-b4567d77f630&ccId=19000101_000001&jobId=575793&lang=en_US&source=CC2