What are the responsibilities and job description for the Quality Engineer position at Copan Diagnostics, Inc.?
Quality Enginner Exempt Test.pdf
QUALITY ENGINEER
Job Summary:
The Quality Engineer will provide quality assurance support to the product development team, resolving bugs, defects, and other potential issues and ensuring that products meet customer specifications.
Supervisory Responsibilities:
- Schedules, organizes and assigns projects to members of the Quality Assurance team.
- Conducts performance evaluations for Quality Assurance team.
- Trains Quality Assurance team in appropriate quality processes and procedures.
Duties/Responsibilities:
- Reviews design plans, process procedures, test procedures, and quality manuals to understand the scope, requirements, and function of products.
- Develops and implements Standard Operating Procedures for all processes involved in Quality Assurance.
- Conducts internal audits to ensure stringent requirements of ISO certification are met.
- Ensures products meet the organization’s and customers’ quality and product integrity requirements.
- Supports product development or operations team by providing analysis and expertise throughout the inspection process.
- Identifies root causes of problems in the production process; recommends and/or implements corrective measures.
- Analyzes data to identify trends in product quality or defects with the goal of mitigating and preventing recurrence and future defects.
- Performs other duties as assigned.
- Plan, execute, and document validation activities (e.g., equipment qualification, process validation)
- Generate protocols, reports, and related validation documentation
- Collaborate with Planning, Production, and NPI/Product Development teams
- Analyze data trends to improve product quality and process stability
- Support risk management and change control processes
Required Skills/Abilities:
- Excellent verbal and written communication skills.
- Excellent organizational skills and attention to detail.
- Extensive knowledge of or the ability to quickly learn the organization’s production processes.
- Excellent interpersonal skills with ability to serve as a liaison with developers, project managers, and customer support.
- Strong analytical and problem-solving skills.
- Proficient with Microsoft Office Suite or related software.
Education and Experience:
- Bachelor’s degree in Engineering or related discipline required.
- Five to Seven years of related experience required.
Physical Requirements:
- Prolonged periods of sitting at a desk and working on a computer.
- Must be able to lift up to 25 pounds at times.
Job Type: Full-time
Ability to travel: 25%