Manufacturing Engineer 8/24/2016

TCS Warsaw, IN

Company
TCS
Job Classification
Full Time
Company Ref #
29270241
AJE Ref #
575973008
Location
Warsaw, IN
Job Type
Regular

JOB DESCRIPTION

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Job Title Manufacturing Engineer

Relevant Experience

Technical/Functional Skills

Prior Zimmer/Biomet experience is preferred.

Skilled and knowledgeable in manufacturing and product processing

Knowledge and working application of Validation Principles and guidelines and medical devices industry practice.

Must have prior experience with IQ/OQ/PQ - equipment validation and process validation experience needed.

Strong understanding of statistical analysis tools and methods knowledge and experience in cGMP CAPS, root cause analysis, risk assessment and investigation tools and techniques

Experienced in GMP and 21 CFR Part 11

Knowledge and working application of FMEA and Risk Analysis.

Ability to effectively work within a team to expedite completion of critical project tasks with other functional groups

Ability to handle project assignments of medium scope and complexity and ability to prioritize and complete work in a timely manner

Demonstrates good problem solving skills through the use of quality and statistical tools

Ability to effectively work within a team and cross-functionally to expedite completion of critical project tasks

Experience Required 4-6

Roles & Responsibilities

Provide validation support by applying manufacturing quality toolset including but not limited to: FTA, FMEA, DFEMEA, PFMEA, IQ, OQ, PQ, analysis, control plans, verification/validation plans, validation protocol development, Cpk, Cp, SPC, DOE, process data analysis, and DMAIC.

Develop and execute IQ, OQ and PQ protocols for product, processes and equipment.

Review existing validation reports and identifies gaps for GMP compliance.

Write reports summarizing results and statistics for all equipment, product, or process validation projects.

Participate as an active member on new product development teams.

Monitor and drive corrective action and continuous improvement activities that directly impact performance measures.

Provide day-to-day support to development, engineering and manufacturing for design control planning and design transfer activities