Quality Engineer - Akkodis : Job Details

Title: Quality Engineer

Location: Warsaw IN

Contract: 24-moths contract

Pay Rate: $40 to $50/hr. (The rate may be negotiable based on experience, education, geographic location, and other factors.)

Position Requirements:

Responsible for the post market activities of existing Design History Files for Medical Devices under the direction of a project leader or manager. Previous system experience with Vault. Excellent communication, teamwork, and organizational skills are essential. Candidates must be self-starters and self-motivators.

Principal Duties and Responsibilities

• Author and Review existing Design History Files, identify scope, and mark gaps where necessary documents are missing
• Utilize Vault Systems to manage Document workflow
• Generate or analyze and update existing risk documentation (DFMEA or risk tables)
• Coordinate, prepare, and conduct design reviews with cross-functional teams
• Perform functional relationship analyses (FRA) and tolerance stack-ups
• Generate comprehensive protocols to test/analyze the product for design verification and design validation (V&V)
• Update prints and other design and manufacturing elements

Expected Areas of Competence

• Familiarity with drafting standards and geometric dimensioning and tolerancing (GD&T)
• Strong Background in DHF documentation authoring and executing for Medical Devices
• Ability to effectively work within a team to expedite completion of critical project tasks with cross functional groups including Regulatory and Quality
• Establishing a process method which meets performance and quality requirements
• Ability to give clear and concise oral presentations
• Technical writing
• Microsoft Office Suite

Education Requirements

B.S. degree from an ABET accredited school (or global equivalent) in Biomedical, Mechanical, or Materials engineering, or equivalent.

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan.

Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

The California Fair Chance Act

Los Angeles City Fair Chance Ordinance

Los Angeles County Fair Chance Ordinance for Employers

San Francisco Fair Chance Ordinance