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Quality Assurance Engineer II

Hainesville, IL 60073

Posted: 09/11/2024 Employment Type: Contract Job Category: QA/Automation Job Number: 614104 Is job remote?: Yes Country: United States

Job Description


Target Pay Rate: 35.33/hr **salary will be commensurate with experience 

SUMMARY:

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

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.

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.

EDUCATION/EXPERIENCE REQUIRED:

Bachelors degree in Engineering and 1-3 years of Medical Device experience

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

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.

Client 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.


**CO/NY candidates may not be considered 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Hainesville, IL

Ready to take the next step in your career? Explore our job opportunities in the vibrant area surrounding Hainesville, Illinois! Nestled in Lake County, this charming region offers a perfect blend of suburban tranquility and urban excitement. With easy access to Chicago for weekend adventures, Hainesville boasts a thriving community, renowned for its picturesque landscape, delicious local cuisine, and a rich cultural scene. Don't miss the chance to visit the Dunes State Park, catch a show at the Genesee Theater, or cheer on the Chicago Bears at Soldier Field. Join us in discovering all that Hainesville has to offer – where career growth meets small-town charm.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.