Senior Quality Manufacturing Engineer
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Job Location:
Bloomington, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
10 hours ago
Vacancies:
1 Vacancy
Job Summary
Overview
The Quality Engineer serves as the lead quality representative of certain product lines within manufacturing.
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 non-conformance/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 maintain all training requirements for the position while seeking out opportunities for continuous development and growth.
- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820 ISO 13485 and other applicable regulatory requirements.
Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
- Must strictly adhere to safety requirements.
- Maintain regular and punctual attendance.
- Must maintain company quality and quantity standards.
- Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with
minimal supervision.
- Ability to remain calm and receptive in fast paced situations.
Qualifications
- Engineer degree and 5-8 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.
Required Experience:
Senior 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.
