POSITION TITLE: Quality Engineer
TITLE OF IMMEDIATE SUPERVISOR: Quality Assurance Manager / General Manager
Develops, initiates, implements, maintains and evaluates standards /methods for manufacturing, engineering, testing, and inspection, using mechanical/process/electrical engineering knowledge in support of internal and external quality and regulatory requirements.
MAJOR DUTIES AND RESPONSIBILITIES: (Core functions are italicized)
· Provide experienced direction/assistance in developing/implementing processes, procedures and controls in an existing ISO9001 / AS9100 / ISO13485 electronics manufacturing environment in order to comply with ISO, FDA, and other applicable regulatory requirements for manufacture electronic devices.
· Oversee the development and execution of validation programs and reports (IQ/OQ/PQ) in compliance with. FDA QSRs
· Oversee, develop and implement validation documentation (e.g., master plans, protocols, change controls, summary reports, etc.).
· Conduct audits of various manufacturing processes to evaluate and determine compliance to additional requirements. Ensure compliance with world-wide regulatory requirements (ISO13485, FDA QSRs etc.)
· Maintain and review established inspection processes and points, and establish new ones as necessary
· Make recommendations for procedure revisions necessary to meet ISO and other regulatory requirements and GMP’s.
· Manages the internal audit process.
· Manages risk assessment of manufacturing processes
· Direct the development of systems for measuring compliance with Quality Systems required for manufacturing of Electronic Systems. Recommend corrective action as required.
· Ensure facility inspection readiness.
· Coordinate and present compliance verification documentation to external auditors.
· Coordinates efforts with all engineering disciplines, purchasing and program management.
· Bachelor’s Degree in Engineering or equivalent experience.
· A detailed knowledge of ISO requirements is required.
· Prior experience in electronic device manufacturing and a working knowledge of QSRs
· Minimum 5 years experience in an ISO environment.
· Minimum 2 years in a role key to implementation of regulatory requirements
· Ability to interpret and apply FDA and GMP regulations/practices.
· Prior experience working at an ISO 9001 registered facility preferred
· Strong PC skills, MS Office (CAD/SolidWorks ideal, Minitab)
· Ability to interpret and convey procedural information
· Excellent oral/written communication skills
· Ability to work in a team environment
TYPE AND DEGREE OF COMMUNICATION:
· Extensive interaction with others at many organizational levels in a variety of departments.
· Excellent interpersonal skills.
· No supervisory responsibilities.
· Responsible for own productivity with some direction from manager.
· Work is performed in good conditions with clean surroundings, air conditioning, good light, proper ventilation and comfortable temperatures.
· Most of the work is performed in a manufacturing environment in a standing position or in an office in a sitting position.
· No accident or health hazards involved. Some exposure to injuries such as bruises etc.
· Operates various types of office equipment.
· Exposure to a serious hazard is unlikely.
SAFETY EQUIPMENT REQUIRED:
Safety glasses required in designated areas of manufacturing.
Job Type: Full-time
Salary: $20.00 to $30.00 /hour
- quality engineer: 1 year (Preferred)
- manufacturing: 2 years (Preferred)
- quality function: 2 years (Required)
- Electronics Manufacturing: 1 year (Preferred)
- Health insurance
- Dental insurance
- Vision insurance
- Retirement plan
- Paid time off
- Relocation assistance
- Tuition reimbursement
- Monday to Friday
- 8 hour shift