Quality Engineer

Job Summary

Maintain and continuously improve the Quality Management System to comply with the most current quality system standards. The Quality Engineer is responsible for all Quality Assurance / Quality Control processes, including internal auditing, quality improvement activities, regulatory compliance, as well as interaction with customers and suppliers.

Duties and Responsibilities

• Receive/track/investigate and respond to customer complaints including issuing RMA’s

• Review and lead solutions for Non-Conformance management
• Setting up and maintaining control and documentation procedures.
• Responsible for monthly reporting of KPIs.

• Leads/supports corrective and preventative action (CAPA’s) management

• Oversite of Calibration program including maintaining GageTrak

• Risk management plan and life cycle maintenance required for adherence to ISO 13485 and ISO 9001.
• Once 30,60,90 goal objectives are met position will be become a Management Representative to maintain ISO 9001 & ISO 13485 certificates

• Data analysis and trending to drive continuous improvement

• Formulating and manage the development and implementation of goals, objectives, policies, procedures for QMS standards.
• Approving and facilitating customer required validation activities

Education

Min/Preferred

Education Level

Description

Required

Associates or 4 Year / Bachelor’s Degree

Engineering or related field.

Experience

Min/Preferred

Experience

Description

Required

2 years

Quality Management System.

KSA's

• Strong problem solving, decision making, and process improvement skills.

• Excellent interpersonal and communication skills.

• Ability to determine and meet deadlines.

• Ability to work independently as well as part of a team.

• Analytical thinking skills.

• Strong understanding of quality systems, ISO 9001 & ISO 13485

Physical Demands

Demand

Frequency

Sitting

Frequent

Standing

Frequent

Walking

Frequent

Use hand/fingers to grasp/pinch/grip

Occasional

Climbing (stairs/ladders) or balancing

Not Applicable

Stoop, kneel, crouch, or crawl

Not Applicable

Operating machinery and/or power tools

Occasional

Operating motor vehicles or heavy equipment

Not Applicable

Activity

Weight Demand

Frequency

Lift

15-20lbs

Occasional

Carry

15-20lbs

Occasional

Push

15-20lbs

Occasional

Pull

15-20lbs

Occasional

Work Environment

• Work performed in an office environment. The noise level in the work environment is usually low.

• May be exposed to production floor environment. The noise level on the production floor can be loud.

Disclaimer

Clayens, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.