Quality Engineer 1, Manufacturing

Posting Date 1 month ago(11/1/2022 8:40 PM)
Requisition ID
2022-11778
Job Location(s)
Bloomington IN United States
Travel
Less than 10%
Position Type
Full Time
Company
Cook Inc - Bloomington
Category
Quality

Overview

The Manufacturing Quality Engineer serves as the lead quality representative of assigned product lines for new product development, day to day manufacturing support, non-conformance, and acts as the independent review function. The Manufacturing Quality Engineer supports additional process such as Supplier Quality, Internal Audit, CAPA, and Post Market Surveillance. The Manufacturing Quality Engineer fulfills the role of both contributor and independent reviewer for their assigned product lines.

Responsibilities

• Performance of risk assessments, internal product and process non-conformances, quality investigations, independent projects and containment activities
• Support/asses/develop continual improvement activities in response to non-conformances and other quality data metrics
• Review/approve validations, test methods, protocols, monthly non-conformance reports, change requests, risk management files and other documents
• Own or assist with internal investigations and CAPA's
• Work with Quality Assurance and Production Engineering to verify/validate critical processes/products and apply control mechanisms around those processes/products so they can be effectively monitored
• Trending of data and data analysis
• Ensure compliance to quality system policies & department procedures
• Maintain accurate timely reports and records

Qualifications

• Bachelor's degree in Engineering or related technical field; at least 5 years of experience in Quality Engineering, Manufacturing Engineering or Development Engineering
• Knowledge of medical device regulations, pertinent standards and guidances
• Knowledge of quality tools and principles

• Experience in project management and managing multiple activities preferred

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