Quality Engineer 2
Cook Medical
Date: 4 weeks ago
City: Bloomington, IN
Contract type: Full time
Overview
The Quality Engineer at Cook Inc. serves as the lead quality representative of certain product lines within product development, manufacturing, post-market surveillance, and/or CAPA.
Responsibilities
The Quality Engineer at Cook Inc. serves as the lead quality representative of certain product lines within product development, manufacturing, post-market surveillance, and/or CAPA.
Responsibilities
- Perform work per external and internal quality standards
- Interface with internal and external groups on quality-related issues
- Support product development and transfer to manufacturing
- Facilitate development and implementation of production controls (e.g. qualification, process capability, sampling plans, validation, etc.)
- Perform investigation of product nonconformance/complaints, root cause analysis, monitoring/trending of process and product, and escalation of identified issues
- 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.
- Provide leadership in the understanding of medical device regulations and best practices
- Manage conflict resolution as it relates to technical situations
- Must work and interact effectively and professionally with and for others throughout various levels of the organization
- Must strictly adhere to safety requirements
- Bachelors degree in a engineering
- 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
- Works under general office environmental conditions, including time in manufacturing environment and biohazard lab
- Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
- Occasional travel may be required
How to apply
To apply for this job you need to authorize on our website. If you don't have an account yet, please register.
Post a resumeSimilar jobs
Educators Wanted
Epic,
Bloomington, IN
3 weeks ago
Please note that this position is based on our campus in Madison, WI, and requires relocation to the area. We recruit nationally and provide financial relocation assistance.As a Trainer you’ll lead in-person and virtual training sessions for physicians, nurses, and other healthcare users in addition to our own staff. You will be the first point of contact for many of...
Junior Windows Engineer
Epic,
Bloomington, IN
3 weeks ago
Please note that this position is based on our campus in Madison, WI, and requires relocation to the area. We recruit nationally and provide financial relocation assistance.We are seeking an exceptional early-career IT professional to join us as a Windows Engineer on our multi-tenant Hosting team. In this role you'll be responsible for the design, implementation, and health of our...
Qa Coordinator
ResCare Community Living,
Bloomington, IN
3 weeks ago
Our CompanyResCare Community LivingOverviewConducts case file record reviews for compliance with regulations/company processes and identifies opportunities for improvement or corrective actions to ensure contractual performance expectations.Responsibilities Conducts Site Reviews at locations as assigned and submit results. Participate in the Pre-Survey Review process. Review incident reporting and initiate follow up when needed. Participate in follow up with Corrective action plans (survey,...
