Quality Engineer 2, Manufacturing
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Job Location:
Bloomington, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
9 hours ago
Vacancies:
1 Vacancy
Job Summary
Overview
The Quality Engineer at Cook 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 othersthroughout various levels of the organization
Must strictly adhere to safety requirements
Qualifications
Bachelors degree Biomedical Engineering Mechanical Engineering Industrial Engineering
3-5 years of experience
Demonstrates knowledge of medical device regulation (ISOCFR) 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
Physical Requirements:
Works under general office environmental conditions including time in manufacturing environment and biohazard lab
Sitting for extended periods utilizes close visual acuity for working withcomputers equipment etc.
Occasional travel may be required
Required Experience:
IC
Key Skills
- Lean Manufacturing
- Six Sigma
- CNC Programming
- Lean
- Machining
- Tooling
- CAD
- CNC
- Assembly Experience
- SolidWorks
- Kaizen
- Manufacturing
About Company
Cook Medical is a family-owned medical device company that works with physicians to develop devices that are less invasive for patients.
