Quality Engineer
Job Juncture | South Killingly, CT, USSalary Range:$70,000 – $92,000 Salary range estimated by Zippia
Posted 15 days ago
Description
Summary: Our Client seeks an experienced Quality Engineer to be responsible for driving operational excellence with our Client's group by providing technical and hands-on support for Operations, Secondary Operations and New Product Development. The successful individual will be a leader that works on cross functional initiatives that improves product quality while reducing cost through work process improvements.
Essential Duties & Responsibilities:
Required Qualifications:
Preferred Qualifications:
Physical Requirements:
Essential Duties & Responsibilities:
- Maintain the quality system in compliance with ISO 13485 and other relevant international standards and regulations.
- Understands business priorities, leads, and supports a culture of quality and compliance while communicating and ensuring the team is focused on initiatives that help meet quality objectives and improve effectiveness of the quality system.
- Build and maintain positive and productive working relationships with all departments and current/potential suppliers while supporting and collaborating with other departments on quality requirements and associated processes.
- Oversee and lead quality activities including but not limited to:
- CAPAs, complaints
- Non-conforming product/process
- Support internal and external audits; may serve as Lead Auditor for internal audits.
- Data analysis
- Document control / Change control
- Equipment calibration
- Control of quality records
- Incoming, in process and final inspections
- Training program
- Communicates for the Quality Team to the Extrusion, Filmcast, Assemblies and New Product Development Teams on abilities and constraints when they exist.
- Establish and/or modify quality processes to improve operational efficiencies and simplicity.
- Develop and monitor quality metrics and goals and provide data-driven recommendations to senior management.
- All other responsibilities as assigned by supervisor.
Required Qualifications:
- Bachelors Degree in Plastics, Mechanical, Chemical or Biomedical Engineering
- Minimum 5 years experience in a manufacturing environment
- ASQ Certified Manager of Quality/Organizational Excellence, ASQ Certified Quality Auditor, ASQ Certified Quality Engineer or ASQ Certified Six Sigma Black Belt
- Working knowledge of ISO 13485:2016
- Extensive knowledge of REACH, ROHS, Conflict Mineral, Prop 65, Material Declarations
- Must possess excellent technical and interpersonal skills
- Must have good written and oral communication skills, self-motivated, and have good organization and project management skills.
- Must demonstrate initiative, balanced assertiveness, flexibility and teamwork.
- Skills and ability to interpret Engineering Drawings, Specifications in regards to manufacturing.
- Working knowledge of GR&R, PFMEA, Cpk, Ppk, IQ/OQ/PQ and SPC.
- Proficient in the use of Micrometers, Verniers, Vision Systems, Pin Gages, and related precision measuring instruments.
- Gage calibration systems to include recall/schedules for recalibration.
Preferred Qualifications:
- Bachelors Degree in Mechanical Engineering, Electrical Engineering, or Chemical Engineering
- 10 years experience in a medical device company
- Certified Manager of Quality/Organizational Excellence, ASQ Certified Quality Auditor, ASQ Certified Six Sigma Black Belt
- Working knowledge of Statistical Process Control (Minitab), Microsoft Office, plastic extrusion, molding or plastic materials science knowledge, or related experience preferred.
Physical Requirements:
- Position requires data entry and regular use of computer/keyboard/mouse for extended periods of time.
- The employee must occasionally lift and/or move up to 20 pounds.