Quality Engineer

Flex•Buffalo Grove, IL

1d•Onsite

About The Position

Flex is a diversified manufacturing partner that helps market-leading brands design, build, and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. The Quality Engineer will be based in Buffalo Grove, IL, reporting to the Quality Engineer Manager, and will be responsible for maintaining quality engineering programs, standards, and improvements within the organization. Flex operates with responsible, sustainable operations and aims to build great products that improve people's lives.

Requirements

Typically requires a bachelor’s degree in related field or equivalent experience
6 years of quality engineer experince
3+ years of medical device, Pharma or Biotechnology industry experince
ISO13485 CAPAS, SCARS, NCMRs experince

Nice To Haves

ISO/FDA certification (prefer)

Responsibilities

Develops and initiates standards and methods for inspection, testing and evaluation.
Devises sampling procedures and designs and develops forms and instructions for recording, evaluating and reporting quality and reliability data.
Develops and implements methods and procedures for disposition of discrepant material and devises methods to assess cost.
Directs workers engaged in measuring and testing product and tabulating data concerning materials, product or process quality and reliability.
Compiles and writes training material and conducts training sessions on quality control activities.
Holds up Product Engineers and Quality Program Managers with customer interfaces as necessary on quality related issues.
Assures data availability and integrity for all quality related data.
Consolidates and reports quality results.
Initiates corrective action requests as needed and tracks to satisfactory completion.
Assists with development and implementation of quality audits.
In charge of developing, applying, revising and maintaining quality standards for processing materials into partially finished or finished products.
Designs and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment.
Explores reports and returned products and recommends corrective action.
Establishes program to evaluate precision and accuracy of production equipment and testing, measurement and research of equipment and facilities.
Approves product, process and equipment qualifications.
Provides liaison to various regulatory bodies.