- 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
- 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
- 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.
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Quality Engineer - Wallingford, United States - Clayens
Description
Job Description
Job DescriptionJob 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
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
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
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.
