USA - Quality Assurance Engineer II

Mindlance; Round Lake (IL); Remote; USD 60,000 - 90,000; Full time

Job summary

An innovative company is seeking a Quality Engineer to lead investigations into quality complaints within the medical device sector. This role involves analyzing data, identifying trends, and developing strategies to enhance quality systems and compliance. The ideal candidate will have a Bachelor’s degree in Engineering and experience in the medical device industry. You'll be working in a regulated environment, ensuring adherence to strict quality standards while driving continuous improvement initiatives. Join a forward-thinking team that values your expertise and commitment to quality.

Qualifications

• Experience in the medical device industry with knowledge of 21CFR820.
• Strong analytical problem-solving skills and ability to manage projects.

Responsibilities

• Investigate and analyze quality complaints and trends.
• Develop strategies for compliance and continuous improvement.

Skills

Medical Device Experience

Investigational Research Skills

Statistical Software Packages (Minitab)

Analytical Problem Solving

Understanding of FDA cGMP

Technical Understanding of Engineering Principles

Computer Competency (Word, Excel, PowerPoint)

Education

Bachelor’s degree in Engineering

Tools

Minitab

CAD Software

Job description

Same as BXTRJP00025547
Remote

I. SUMMARY:
This description outlines the employment prerequisites and job responsibilities for the position of Engineer, Quality Complaint Investigations.

II. ESSENTIAL FUNCTIONS:

This position has primary responsibility for investigation, review, and completion of all Quality Engineering complaint issue analysis tasks utilizing various quality system inputs.

Review individual complaints and associated service data to determine risk level and complete investigation into the “as “determined” problem code and cause codes for each complaint.
Analyze data from various quality inputs (including but not limited to: Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to determining trends and systemic issues. Prepare and issue reports based on information analysis.
Review existing investigation reports and identify gaps for GMP compliance. Develop strategies and plans to close the gaps in an efficient and technical manner.
Develop and communicate expectations for quality performance, continuous improvement and process controls for marketed products.
Monitor and drive corrective action and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions.
Conduct or lead corrective and preventive actions in manufacturing using formal problem-solving tools and documentation.
Support CAPA and maintenance activities for existing product lines.
Recommend and/or support projects for improvements to the quality system as approved by management.

III. QUALIFICATIONS, KNOWLEDGE, AND SKILLS REQUIRED
To perform this job successfully, and individual must be able to perform each essential duty satisfactorily.
Medical Device Experience with knowledge of 21CFR820 preferred.
Investigational research skills
Experience with any statistical software packages (Minitab a plus)
Desired experience in the medical device industry in the development and deployment of Quality Systems, and process controls, and continuous improvement methods.
Knowledge and working application of FDA cGMP; ANSI/ISO/ASQC requirements; CMDAS (optional).
Knowledge and working application of reading and understanding blueprints and technical drawings.
Demonstrated strong analytical problem solving (Root Cause Investigations.
Display a solid technical understanding of engineering principles and procedures (e.g. CAD and its application or scheduling a series of technical tasks utilizing software-based tools).
Computer competency in Word, Excel, Power Point, Minitab, Access and databases.
Ability to multi-task and methodically manage projects.

IV. EDUCATION/EXPERIENCE REQUIRED

A Bachelor’s degree in Engineering and 1-3 years of Medical Device experience

V. PHYSICAL DEMANDS
Able to exert up to 10 pounds of force occasionally.
Able to sit, stand, walk throughout the workday.

VI. WORK ENVIRONMENT
Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Baxter is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture. Some of those work rules include but are not limited to:
Wearing a static protective smock at all times while in the manufacturing work area
Working in close proximity to other employees.
Working in an environment that is temperature and humidity controlled.