What are the responsibilities and job description for the Onsite Medical Device Quality Engineer position at Akkodis?
Akkodis is seeking an Onsite Medical Device Quality Engineer for a contract job with a client in Bloomington, IN. You will work primarily with the Engineering Department personnel and other functional groups, as needed, to review and approve documents for process development. This is an onsite contract opportunity through 2025.
Rate Range: $60.71/hr; The rate may be negotiable based on experience, education, geographic location, and other factors.
Onsite Medical Device Quality Engineer job responsibilities include:
• Quality Engineering review of Design Control Documents, Risk Control Documents, Test Method Validation Documents and possibly Process Validation Documents per applicable Quality System Procedures and Instructions
• Execute risk assessment as needed and facilitate development and completion of risk file documentation
• Conduct Risk-based decision making and effective resolution of issues
• Provide leadership in the understanding of medical device regulations and best practices
• Meet and/ or beat designated deadlines
• Generate quality outputs for Design History File documents (generation of a PFMEA, etc.)
Desires Qualifications:
• Bachelor’s Degree in Mechanical, Biomedical or Chemical Engineering
• Requires five plus years of experience with sterile barrier/ packaging in medical device manufacturing.
• Demonstrate the understanding of medical device regulations and best practices
• Demonstrate a proficiency in statistical, quality and continuous improvement methods and Tools
• Demonstrate knowledge of medical device regulation (ISO 13485, 21 CFR) and risk management (ISO 14971).
• MS Office proficiency. Excellent use of Microsoft Word, Excel. Minitab a plus
• Strong technical understanding of manufacturing, process development, and process validation/ quality
• Must work well with others, have good problem-solving skills and have excellent communication skills (ability to summarize)
• Experience with Design History Files (DHF) and PFMEA’s
If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis go to www.akkodis.com.
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.
To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy.
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
Salary : $61
