Quality Engineer

Role: Quality Engineer
Location: Raynham, MA
Client: TCS
Position Type - Fulltime

Job Description:

Must have skills

• 3 to 5 yrs. of experience in Med Device environment as a Quality Engineering and/or Validation role
• Developing, writing, reviewing, maintaining and revising manufacturing documentation, i.e., Process Work Instructions, Manufacturing Specifications, Inspection Procedures to support product Manufacturing
• Developing, writing, and reviewing IQ/OQ/PQ documentation for manufacturing processes and/or manufacturing equipment in conjunction with Manufacturing Engineering partners.
• 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

Good to have skills

• Knowledge of statistical data analysis tools (e.g., Minitab).
• Basic knowledge of Geometric Dimensioning and Tolerancing (GD&T)
• Experience working in both an FDA and European regulatory environment in manufacturing/operations.
• A thorough understanding of GMP/ISO regulations and validation regulations
• The ability to perform "hands on" troubleshooting and problem solving.
• Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook).
• 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.
• Experience with machining processes, metal finishing processes, and production automation
• Experience in a Medical Device work environment.
• Good technical understanding of manufacturing equipment and processes.