4 Quality Engineer Jobs in Spencer, IN
Cook Medical is Hiring a Quality Engineer Near Spencer, IN
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
- Ability to remain calm and receptive in fast paced situations.
- Engineer degree or a Technical Life Science Degree.
- 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.
- Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) of this employment position.**
- 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.
- Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.
Job Summary
Full Time
Medical Technology
$89k-105k (estimate)
05/31/2024
06/26/2024
cookmedical.com
BLOOMINGTON, IN
3,000 - 7,500
1963
M KEM HAWKINS
$500M - $1B
Medical Technology
Related Companies
The job skills required for Quality Engineer include Leadership, Verbal Communication, Attention to Detail, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Engineer. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Engineer. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Quality Engineer positions, which can be used as a reference in future career path planning. As a Quality Engineer, it can be promoted into senior positions as a Quality Assurance Engineer IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Engineer. You can explore the career advancement for a Quality Engineer below and select your interested title to get hiring information.
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