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USA - Quality Assurance Specialist II

2 months ago

Round Lake, Illinois, United States Mindlance Full time
Position Overview:
This document outlines the employment qualifications and responsibilities for the role of Quality Assurance Engineer focused on Complaint Investigations.

Key Responsibilities:

This role is primarily accountable for the investigation, assessment, and resolution of all Quality Engineering complaint analysis tasks utilizing various quality system inputs.

Evaluate individual complaints and related service data to ascertain risk levels and conduct thorough investigations into the identified problem codes and cause codes for each complaint.

Examine data from diverse quality inputs (including but not limited to: Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to identify trends and systemic issues.

Prepare and disseminate reports based on data analysis.

Review existing investigation reports to identify compliance gaps with Good Manufacturing Practices (GMP). Formulate strategies and plans to address these gaps efficiently and technically.

Establish and communicate expectations for quality performance, continuous improvement, and process controls for marketed products.

Oversee and drive corrective actions and continuous improvement initiatives that directly influence performance metrics by conducting primary investigations, performing data analysis, and implementing corrective measures.

Lead or facilitate corrective and preventive actions in manufacturing using formal problem-solving methodologies and documentation.

Support Corrective and Preventive Action (CAPA) and maintenance activities for existing product lines.

Advise and/or assist in projects aimed at enhancing the quality system as sanctioned by management.


Qualifications, Knowledge, and Skills Required:
To excel in this position, an individual must be capable of fulfilling each essential duty satisfactorily.

Experience in the Medical Device sector with knowledge of 21CFR820 is preferred.

Research skills related to investigations.

Familiarity with statistical software packages (Minitab is advantageous).

Preferred experience in the medical device industry concerning the development and implementation of Quality Systems, process controls, and continuous improvement methodologies.

Understanding and practical application of FDA cGMP; ANSI/ISO/ASQC standards; CMDAS (optional).

Ability to read and interpret blueprints and technical drawings.

Proven analytical problem-solving skills (Root Cause Investigations).

Demonstrated technical understanding of engineering principles and procedures (e.g., CAD applications or scheduling technical tasks using software tools).

Proficiency in Microsoft Word, Excel, PowerPoint, Minitab, Access, and databases.

Capability to manage multiple tasks and systematically oversee projects.


Education/Experience Required:
A Bachelor's degree in Engineering and 1-3 years of experience in the Medical Device field.

Physical Demands:
Able to exert up to 10 pounds of force occasionally.
Able to sit, stand, and walk throughout the workday.

Work Environment:

The characteristics of the work environment 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.

This role operates in a manufacturing environment regulated by the FDA and adheres to numerous work rules to prevent product damage.

Some of these work rules include but are not limited to:

Wearing a static protective smock at all times while in the manufacturing area.
Working in close proximity to other employees.
Operating in a temperature and humidity-controlled environment.