Insight Global is seeking a Quality Engineering Consultant to support a critical Production Part Approval Process (PPAP) initiative tied to a customer regulatory submission due in October. This individual will primarily focus on writing and executing Test Method Validations (TMV) and Process Validations, while also contributing to other final PPAP deliverables.
Key Responsibilities:
Lead the writing, execution, and documentation of Test Method Validation (TMV) protocols and reports.
Develop and complete Process Validation activities with minimal oversight.
Collaborate closely with the Quality Engineering team to ensure validation work aligns with regulatory and customer expectations.
Support final elements of the PPAP package, including tasks such as Measurement System Analysis (MSA) and documentation reviews.
Manage change and process validation documentation with a high degree of independence.
Ensure deliverables are completed by end of September to support downstream regulatory submissions.
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Strong hands-on experience with Test Method Validation and Process Validation activities in a regulated environment (preferably medical device or similar).
Proven ability to independently write, execute, and summarize validation protocols and reports.
Solid understanding of PPAP and Measurement System Analysis
Background in Quality Engineering or related technical field, with a strong grasp of documentation and compliance processes.
Detail-oriented, self-driven, and able to ramp up quickly with minimal guidance.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.