- Receive/track/investigate and respond to customer complaints including issuing RMAs
- Review and lead solutions for Non-Conformance management
- Setting up and maintaining control and documentation procedures.
- Responsible for monthly reporting of KPIs.
- Leads corrective and preventative action (CAPAs) management
- Oversight of Calibration program including maintaining GageTrak
- Risk management plan and life cycle maintenance required for adherence to ISO 13485 and ISO 9001.
- This person will be become a Management Representative to maintain ISO 9001 & ISO 13485 certificates once 30,60,90 goal objectives are met position
- 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
- Bachelor's or Associates degree in Engineering or related field
- 2+ years of experience utilizing and maintaining the Quality Management System (QMS)
- Strong understanding of quality systems, ISO 9001 & ISO 13485
- 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 problem solving, decision making, and process improvement skills
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Quality Engineer - Wallingford, United States - CoWorx Staffing
Description
Quality Engineer Onsite in Wallingford, CT
A respected plastic manufacturer in Wallingford, CT is looking for a Quality Engineer to join their team. 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. The Quality Engineer maintains and continuously improve the Quality Management System to comply with the most current quality system standards.
Responsibilities:
Qualifications: