Quality Assurance Engineer

SUMMARY:

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

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

• 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

• A Bachelor of Science degree in Engineering
• 1-3 years of Medical Device experience

PHYSICAL DEMANDS:

The physical demands 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.
• While performing the duties of this job, the employee:
  • Must be able to sit for long periods of time
  • Must have good hand to eye coordination and dexterity
• Physical Requirements: Dynamic Lifting capability: Must have the ability to lift 40 pounds at a time.

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.
• This 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 work area
  • Wearing a ground wrist strap and plugging that wrist strap into the working table.
  • Working in close proximity to other employees.
  • Working in an environment that is temperature and humidity controlled.