Quality, Full Time
As a Quality Engineer for the organization you will be an integral part of the maintenance and improvement of the company’s quality management systems adherence to ISO and Regulatory requirements.
Functions & Responsibilities
In the role of Quality Engineer:
- You will lead CAPA activities and non-conformance investigations
- You will develop and lead implementation of continuous improvement plans
- You will lead supply chain quality management activities including audits and vendor CAPA’s
- You will manage the incoming inspection department
- You will participate in activities to ensure manufacturing processes are properly validated and in compliance with company, ISO, and regulatory requirements
- You will participate in the development of Failure Mode and Effects Analysis (FMEA)
- You will lead internal quality system audits
- You will lead audits from regulatory and safety agencies, customers, and registrars
- You will participate in design reviews as needed
Job Requirements
The skills you need to succeed:
- You must have strong problem-solving skills
- You must have strong goal attainment orientation with team focus
- You must have project/ task management skills
- You must have the ability to work in environments experiencing routine and rapid change
- You must have excellent organization and decision making skills
- You must have strong mentoring and leadership skills
- You must be a self-starter, possessing high degree of self-motivation
Educational Requirements
Education and experience of a successful candidate:
- Bachelor’s degree in a related engineering discipline
- 4+ years related experience in the development and maintenance of quality management system and documentation control processes and procedures
- Related experience in an FDA regulated medical device company is strongly desired
- Strong working knowledge of FDA medical device regulations, and ISO 13485 requirements in quality management systems and documentation control
- Experience with printed circuit board assembly and test highly desirable
- Experience implementing Lean manufacturing and/or Six Sigma projects preferred
- Advanced word processing (Microsoft Word), database (Access) and spreadsheet (Excel) skills
Benefits
- Enercon Technologies offers a competitive benefits package.