Akkodis is seeking an Onsite Quality/ Validation Engineer for an 11-month contract position with possible extension with a client 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.
Pay/Salary Range: $60.71 per hour.
This position offers an allotment of up to $79.00/day for housing (up to $1500/month) and a possible $76.00/day on-site allotment for those who qualify.
Onsite Quality/ Validation Engineer 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.
• Engineer degree or a Technical Life Science Degree.
• Five to eight 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 job in Bloomington, IN then please click APPLY NOW. For other opportunities available at Akkodis go to www.akkodis.com.
Equal Opportunity Employer/Veterans/Disabled
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.Pay Details: $60.71 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, 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.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.modis.com/en-us/candidate-privacy
The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.