Title: Quality Engineer II, InnFocus
Location: Miami, Florida
PRIMARY PURPOSE OF POSITION:
Assist in defining the quality needs during the development of new products and their processes using design and development systems in accordance with FDA and international regulations. Establish and maintain systems to support the overall quality system for manufacturing of products.
MAJOR DUTIES OF POSITION:
- Assists in maintaining the quality system for InnFocus, Inc. in compliance with ISO 13485, the U.S. Code of Federal Regulations, MDR, MDSAP and other designated country regulations.
- Owns and manages activities for the calibration and receiving inspection systems.
- Independently develops new test methods to inspect medical devices. Performs test method validation (TMV) on the developed test method. Writes TMV protocol, plans and executes the validation and writes TMV reports.
- Authors protocols for existing and new equipment, test method validations, process and product performance qualifications, plans the validation and executes as per company validation requirements. Writes detailed validation report upon validation completion and releases within the established document control system.
- Conduct testing of product as needed.
- Owns and manages activities for the calibration and receiving inspection systems
- Generate, modify as needed and follow approved procedures such as GOPs, OPSs, QLPs, etc. for activities conducted.
- Maintain working knowledge of U.S. Quality System Regulations, ISO 13485, MDR and MDSAP.
- Maintain effective communications with supervisor and peers in daily activities.
- Ensure records i.e. test reports, evaluations, protocol reports, etc. are created and maintained in accordance with requirements of InnFocus Standard Operating Procedures.
- Apply appropriate problem-solving techniques for effective root cause analysis and successful corrective action.
- Monitor and intercede in the quality system activities to assure compliance.
- Other quality assurance activities as needed in support of the quality management system.
KNOWLEDGE AND SKILL REQUIREMENTS:
- Four-year degree in sciences or engineering or equivalent experience, plus 2 years related experience.
- Knowledge of inspection equipment is required. As a minimum, experience with calipers, micrometers, pin gauges, and shadowgraph or similar equipment.
- Previous experience in quality control or quality assurance in a medical device environment is a plus.
- A CQE certification is a plus.