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RandD / Quality Engineer (CAPA)

Company: DivIHN Integration Inc
Location: Deerfield
Posted on: June 15, 2022

Job Description:

DivIHN (pronounced Divine) is a nationally-recognized Business Technology Solutions and Staffing services provider headquartered in Chicago. Since our formation in 2002, we have been trusted by Fortune 500 organizations to help them locate and hire best-in-class talent through our Award-winning Professional Workforce Solutions program. -

Check out our careers page to see all of our job openings: -

One of our BEST F500 customers has engaged us to help them hire a -RandD / Quality Engineer (CAPA) to be available -to work out of their office in Deerfield, -Illinois; details can be found below.

12 months

Please apply or call one of us to learn more

For further information please contact our Talent Specialist: Pratichi - 6308470267 Title: RandD / Quality Engineer (CAPA) Location: Deerfield, IL Duration: 12 Months Description: What is the top three to five technical skill requirements? Product life cycle management experience, medical device experience, design development and transfer experience, What is the top three to five soft skill wants? Good verbal and written communication, hard worker, curious to learn new things, critical thinker Is this position onsite or remote? Onsite (hybrid) o If onsite in Deerfield will it follow a hybrid model and what does the look like on your team? Hybrid includes 3 days onsite, 2 remote. What is the expected interview process? I expect to have WebEx interview with camera on with myself and other team members individually. Responsible for supporting the development of new products and on-market products used in surgical procedures. This person should be able to work in a matrix environment through partnerships with RandD and other cross functional team members. This position is in need of a strong understanding of Quality compliance by building quality into products using design control and risk management principles in compliance with regulatory standards and procedures. Essential Duties and Responsibilities: Applies state of the art techniques in the area of expertise to support the development of new or improved products Supports the sustainability and life cycle management of existing products Ensures compliance with global quality systems and Regulatory requirements related to product and process Provides Quality Assurance support and guidance for verification and validation of product requirements Performs design change control activities including impact assessments, reviews, and approvals Takes lead role in CAPA activities such as investigation, implementation, or verification of effectiveness Supports risk management activities as they relate to product and post market surveillance Interacts with on-shore and off-shore suppliers to complete project related activities Applies a solid understanding of theories/practices utilized by other disciplines outside the primary area of expertise toward the development of new or enhanced products Plans, executes, and works with minimal supervision and independent judgment Qualifications: Must have experience working with all classes of Medical devices preferably implantables, Biologics, and/or combination products with advanced training and demonstrate proficiency in problem solving, total quality management, DHF remediation, Risk file remediation, EUMDR, problem analysis and resolution, and design of experiments Experience with New product development activities as RandD lead or QE lead in various product development teams Demonstrates leadership skills to handle sustaining product support activities involving Complaint investigations, Trigger evaluations and Change controls Extensive cross-functional team experience, including technical and non-technical work Strong interpersonal, communication, influencing, and negotiation skills Education and Experience: B.S. degree in Engineering with at least 1-3 years of experience working in a regulated environment Higher degrees desired with relevant experience in medical device industry Demonstrated success in delivering results on several technical challenges Working knowledge of medical device international standards About us: DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration. DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status. Job Requirements:RandD, Risk file remediation, quality management

Keywords: DivIHN Integration Inc, Arlington Heights , RandD / Quality Engineer (CAPA), Other , Deerfield, Illinois

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