Quality Validation Engineer

Quality Validation Engineer at Akkodis Quality Validation Engineer at Akkodis in Beverly, Massachusetts Posted in 1 day ago.

Type:

full-time

Job Description:

Akkodis is seeking a Quality Validation Engineer for a contract job in

Danvers, Massachusetts, United States, Onsite Pay Range:

$45/hr - $47/hr on W2 (The rate may be negotiable based on experience, education, geographic location, and other factors.

Postion :

Quality Validation Engineer Location:

Danvers, Massachusetts, United States, Onsite Duration:

12M+, Possibile to extend

Domain Experience:

Manufacturing, Validation, Quality, Test Method with Gage R&R Stufies Experience We are seeking a highly motivated Quality Valdation Enfgineer to support Test Method Validation, support the development, validation, and lifecycle management of test methods used in the design, manufacturing, and quality control of medical devices. The Quality/TMV Engineer will ensure that inspection and testing methods are scientifically sound, compliant with regulatory requirements, and capable of producing accurate, reliable, and repeatable results. This role partners closely with R D, Quality Assurance, Manufacturing, Regulatory Affairs, and suppliers to support product development and commercial manufacturing activities. Key Responsibilities Develop, execute, and document test method validation (TMV) studies for medical device products and components. Design validation protocols and reports in accordance with FDA, ISO, and internal quality system requirements. Perform statistical analyses including Gage R&R, accuracy, precision, linearity, repeatability, reproducibility, and measurement uncertainty assessments. Evaluate and validate laboratory, inspection, and manufacturing test methods. Support design verification and validation activities throughout the product development lifecycle. Collaborate with cross-functional teams to establish acceptance criteria and testing strategies. Investigate test failures, measurement system issues, and out-of-specification results. Ensure compliance with applicable regulations, including

FDA 21 CFR

Part 820 and

ISO 13485.

Maintain validation documentation, technical files, and design history records (DHR/DHF). Support audits, regulatory inspections, and quality system assessments. Identify opportunities for process improvement and implementation of best practices in validation activities. Required Qualifications Bachelor's degree in Mechanical Engineering, Quality Engineering, or a related technical discipline. 2-5+ years of experience in test method validation, quality engineering, or medical device product development. Experience with statistical tools such as Minitab, JMP, or equivalent software. Strong understanding of measurement systems analysis (MSA) and Gage R&R methodologies. Knowledge of FDA and international medical device regulations. Experience writing validation protocols, reports, and technical documentation. Strong analytical, problem-solving, and communication skills. To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy. The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance