Quality Engineer

Akkodis is hiring an Onsite Quality/ Validation Engineer for a client in the Medical Device Manufacturing industry located in Bloomington, IN. You will serve as the lead quality representative of certain product lines within product development, manufacturing, post-market surveillance, and/or CAPA. Must have's

experience: Validation, remediation, NPI.

Pay: $60.71 per hour.

Onsite: Bloomington, IN

Job

responsibilities include:• Perform work per external and internal quality standards. Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory

requirements. Provide leadership in the understanding of medical device regulations and best practices.• Interface with internal and external groups on quality-related issues. Must work and interact effectively and professionally with and for others throughout various levels of the global organization. Must have effective communication

skills and ability to work in a collaborative and independent work situations and environments with minimal supervision.• Support product development and transfer to manufacturing.• Facilitate development and implementation of production controls. (e.g., qualification, process capability, sampling plans, DOE reviews, validation reviews, technical writing etc.)• Perform investigation of product non-conformance/complaints, root cause analysis, monitoring/trending of process and product, and escalation of identified issues. Validation execution. Thorough review of technical documents.• Plan, review, and approve change requests.• Execute risk assessment as needed and facilitate development and completion of risk file documentation. Conduct Risk-based decision making and effective resolution of issues.• Lead or support CAPAs as necessary.• May interface with internal or 3rd party audits. (e.g., FDA, Notified Body, etc.)• Drive continuous improvement efforts through facilitating, leading, and collaborating with cross function teams including quality, engineering, production, clinical, and regulatory affairs.• Manage conflict resolution as it relates to technical situations.• Must maintain all training

requirements for the position, while seeking out opportunities for continuous development and growth.

QUALIFICATIONS:• Bachelor’s degree: Mechanical or Biomedical Engineering• 3-5 years of

experience process and equipment validation and TMV in a regulated manufacturing environment position. Packaging or sterile barrier

experience a plus.• Demonstrates knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971)• Professional certification (e.g., ASQ, Six Sigma, etc.) preferred.• Proficiency in statistical, quality, and continuous improvement methods and tools.• Proficiency in the Microsoft Office suite of products (Word, Excel, PowerPoint, and Outlook) is required.• Strong organizational

skills.• Critical thinking and attention to detail required.• Excellent verbal communication

skills and technical writing.• Ability to remain calm and receptive in fast paced situations.

If you are interested in this Onsite Quality/ Validation Engineer position in Bloomington, IN then please click APPLY NOW.

For other opportunities available at Akkodis go to www.akkodis.com.

Equal Opportunity Employer/veterans/disabled

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary

benefits, commuter

benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.modis.com/en-us/candidate-privacy/

The Company will consider qualified applicants with arrest and conviction records.