POSITION SUMMARY:

The Quality Engineer’s goal is to maintain a strong Quality System with an emphasis on continuous improvement. Key responsibilities include managing complaints, corrective actions, and product qualification processes. Additional duties involve compliance support, audit processes, and continuous improvement initiatives. The individual acts as a leader in the department using strong organizational, problem-solving, and collaborative abilities.

EDUCATION AND EXPERIENCE:

• Bachelor’s Degree required; preferred in a technical field
• Must have experience in a high compliance manufacturing environment

KNOWLEDGE SKILLS AND ABILITIES:

Knowledge

• Quality and Compliance: Strong knowledge in quality assurance principles, methodologies, and regulatory standards (e.g., ISO, FDA, or similar)
• Core Technical Expertise: Basic understanding of material properties, mechanical systems, and manufacturing processes
• Data Analysis: Six sigma or similar statistical experience

Skills

• Computer Skills: Strong computer proficiency, including Microsoft Office Suite / 365
• Problem Solving: Strong analytical and problem-solving skills, with a focus on data-driven decision-making
• Root Cause and Corrective Action: Proven success in root cause analysis and corrective/preventive actions

Abilities

• Organization, Time Management, Multi-tasking: Excellent organizational and time management ability
• Collaboration: Exceptional communication and interpersonal skills to interact effectively with customers, vendors, and cross-functional teams
• Industriousness: Proactive and rigorous approach to problems

PHYSICAL REQUIREMENTS / WORKING CONDITIONS:

The physical demands described represent those that must be met by an employee to successfully perform the essential functions of this 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 is regularly required to sit, stand, walk, climb, stoop, kneel, and crouch. The employee is occasionally required to balance or crawl. The employee is required to regularly operate a computer and other office machinery such as a copy machine and printer. The employee is required to regularly reach with arms and hands; use hands to handle, finger or feel objects, tools or controls. Hands and fingers may frequently perform repetitive motion. Occasionally the employee will use arms and hands to balance and climb. The employee must frequently lift and/or move up to 10 pounds. Occasionally the employee will lift and/or move up to 25 pounds with the use of a lift assist. This job requires close vision, peripheral vision, depth perception and the ability to adjust focus. Employee is required to regularly talk and hear. The person in this position frequently communicates to other employees/personnel as well as customers and must be able to exchange accurate information.

Product Qualification and Change Control

• Product / Process / Equipment Validation - Work with Engineering and others as needed to create protocols, perform qualifications, perform or facilitate testing and record results.
• Create, execute, and facilitate other test plans (PPAPs, FAIs, etc.)
• Execute quality section of Engineering Change Orders
• Create Control Plans
• Support the creation of PFMEA

Non-Conformance and Corrective Action

• Manage Complaint and Corrective Action program through clear documentation, holding others accountable, task management, coaching/training, and clear internal/external communication
• Facilitate and execute containment, root cause analysis, corrective/preventive actions, and verification of effectiveness

Product Qualification and Change Control

• Product / Process / Equipment Validation - Work with Engineering and others as needed to create protocols, perform qualifications, perform or facilitate testing and record results.
• Create, execute, and facilitate other test plans (PPAPs, FAIs, etc.)
• Execute quality section of Engineering Change Orders
• Create Control Plans
• Support the creation of PFMEAs

Quality Technician Support/Leadership

• Support and coach quality technicians as needed in support of team growth and Quality System health.
• Calibration program – Supporting calibration process as needed, including decision making, new equipment, and test plan changes.
• Inspection - Fill in for quality Techs as needed, perform inspection / test and document results.

Audits

• Perform Internal Audits
• Support External Audits
• Review Audit findings, recommend/execute on corrective actions

Quality Management System and Compliance

• Monitor quality system for trends, including contributing to Management Review
• Recommend quality improvement projects based on quality goals established
• Develop/revise QMS documentation, as needed
• Train necessary personnel on quality standards, procedures as required

Requirements: