Job Location : Raynham,MA, USA
Job Title: Quality Validation Engineer (W2)
Location: Raynham, MA (Hybrid)
Duration: Long Term
Job Description:
The Validation Engineer will be primarily supporting Project Knight, which is a large- scale foundry capacity expansion project within the Raynham, MA, manufacturing facility. This position is based on-site as the Quality Engineer II will be required to interface with manufacturing equipment, medical device products, and cross-functional partners.
The daily tasks in scope of this role include but are not limited to the following:
• Developing, writing, reviewing, maintaining and revising manufacturing documentation, i.e. Process Work Instructions, Manufacturing Specifications, Inspection Procedures to support product Manufacturing
• Supporting the development and execution of manufacturing equipment qualifications (URS/FAT/SAT/IQ)
• Supporting the development and execution of process validations (OQ/PQ/PV)
• Developing, writing, and reviewing various validation deliverables, i.e. CSV-E, Engineering Studies, etc.
• Assessing, developing, writing, executing, and reviewing Test Method Validations
(TMVs)
• Developing, writing, reviewing, and updating relevant Process Risk Documentation (pRAS, pFMEA, FMCA)
• Partnering with cross functional partners to ensure sound validation strategy and smooth transitions to production go-live
• Ensuring adequate documentation where necessary within the Quality System In order to successfully deliver on the above the incumbent will apply comprehensive and diverse knowledge of Engineering and Quality Engineering principles and practices as well as problem solving, risk management skills, and communication skills.
Qualifications
Education:
• A minimum of a bachelor's degree in engineering, Science, or related technical field.
Experience and Skills:
• A minimum of 0-5+ years of related experience
• Knowledge of statistical data analysis tools (e.g. Minitab).
• Basic knowledge of Geometric Dimensioning and Tolerancing (GD&T)
• The ability to perform hands on troubleshooting and problem solving.
• Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Strong communication and interpersonal skills.
• Must have the ability to function in a team-based manufacturing environment.
• The ability to collaborate with all levels of management in a cross-functional team environment.
Preferred:
• Experience in manufacturing: metal casting processes, CNC machining processes, metal finishing processes, Gage R&R CNC equipment, plastic or wax injection, laser processing or production automation
• Experience in a Medical Device work environment.
• Good technical understanding of manufacturing equipment and processes.
• Experience working in both an FDA and European regulatory environment in manufacturing/operations.