Quality Engineer 1

The Manufacturing Quality Engineer serves as the lead quality representative of assigned product lines for new product development, day to day manufacturing support, non-conformance, and acts as the independent review function. The Manufacturing Quality Engineer supports additional process such as Supplier Quality, Internal Audit, CAPA, and Post Market Surveillance. The Manufacturing Quality Engineer fulfills the role of both contributor and independent reviewer for their assigned product lines.

- Perform work per external and internal quality standards.
- Perform independent review function per external and internal quality standards.
- Interface with internal and external groups on quality-related issues.
- Be the voice of quality for daily manufacturing in assigned departments by partnering with Operations and Production Engineering and providing guidance on issues in line with external standards, internal standards, and best practices.
- Support product development and transfer to manufacturing.
- Facilitate development and implementation of production processes and controls. (e.g. qualification, process capability, sampling plans, validation, etc.)
- Assist with investigation of product non-conformance/complaints, root cause analysis, monitoring/trending of process and product, and escalation of identified issues.
- Own quality improvement tasks in assigned departments.
- Plan, draft, and route change requests as necessary.
- Execute risk assessment as needed and facilitate development and completion of risk file documentation.
- 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 engineering, production, clinical, and regulatory affairs.
- Provide leadership in the understanding of medical device regulations and best practices.
- 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 ensure compliance to FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.

- Bachelors degree in engineering or scientific discipline.
- >2 years of engineering experience. Any engineering discipline if coming from a medical device background -OR- quality engineering experience from any regulated industry.
- Knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971) is preferred but will consider a candidate with quality experience from any regulated industry.
- 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 with computers, equipment, etc.
• Occasional travel may be required

Cook currently projects the base salary for this position could range from $72,000 to $75,000 and the actual pay will depend on a variety of factors including the candidate’s qualifications, education, experience and the required location for this role. In addition, this role will be eligible for an additional variable bonus opportunity based on company and/or individual performance. Full-time employees will also be eligible for a comprehensive benefits package to include a company-sponsored 401(k) and profit-sharing plan, paid time-off benefits, medical, prescription drug, dental and vision insurance, flexible spending accounts including both healthcare and dependent care, short and long-term disability as well as life insurance. In addition, there are well-being resources to support physical, emotional and financial wellness as well as a comprehensive EAP program. Cook also provides voluntary benefits funded 100% by employees in the areas of critical illness, accident insurance, hospital indemnity and long-term care. Cook offers three different work location options, on-site, hybrid and fully remote. The compensation range described above is always subject to change and could be higher or lower depending on the particular candidate. Finally, in its sole discretion, Cook reserves the right to amend modify or terminate any compensation or benefit program at any time and Cook’s compensation practices and guidelines will apply regarding the terms of promotion or transfer of existing Cook employees.