Quality Engineer

4 weeks ago

Spencer, United States Cook Group Full time

Overview:

The Quality Engineer at Cook Spencer The Quality Engineer 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 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 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.**

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 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.

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