Quality Assurance Engineer Ii

Job Purpose

The Quality Assurance Engineer II works under the instruction of the Manager, Quality Engineering. This position helps to support the manufacturing of medical devices from a quality perspective.

Duties and Responsibilities

• Assure Quality System Processes are in compliance with US-FDA, MDD/MDR, ISO 13485 and other applicable country specific medical device regulations.
• Develop Quality Plans for implementation of new processes or improvements to existing processes
• Conduct internal quality audits to ensure compliance to Quality System and regulatory requirements.
• Facilitate receiving inspection and first article inspection activities. Help establish receiving inspection requirements for materials and any needed inspection/testing procedures.
• Facilitate calibration activities. Help establish calibration requirements for measuring equipment and test fixtures as needed.
• Control of suppliers including supplier approval, supplier audits, supplier monitoring and supplier corrective action.
• Facilitate material review board meetings. Establish and maintain non-conforming material system.
• Daily line support activities in manufacturing.
• Support manufacturing in process validation activities.
• Maintain corrective/preventive action system. Work with responsible engineering personnel to perform root cause analysis, develop and implement action plans, and follow-up on implementation and effectiveness of actions taken.
• Collection and trending of key quality indicators for management review.
• Support transfer of products from development to manufacturing.
• Perform other related functions as required by quality management.

Qualifications

• Bachelor’s degree in a technical field as Engineering or Biological Science and a minimum of five-years experiences in the field of medical device manufacturing, prior experience with medical electronics preferred.
• Ability to work with minimal direct leadership in a fast-paced environment.
• Ability to read and interpret engineering drawings, schematics and specifications.
• Self-motivated, detail oriented, and well-organized with good communication skills, both written and oral.
• Strong analytical problem-solving ability required.
• Proficient computer skills which include the use of Microsoft WORD, EXCEL, and POWERPOINT. Prior use of an electronic document control system, ERP system and FDA eMDR reporting.

Desirable Accreditations/Knowledge

• ASQ Certifications such as Manager of Quality/Organizational Excellence, Quality Engineer, Quality Auditor, Supplier Quality Professional, etc.
• Certified ISO 13458 / MDD lead auditor.

Working Conditions

• A Quality Assurance Engineer II usually works in an office environment which includes laboratory and manufacturing areas. Occasional domestic travel may be required.

• A Quality Assurance Engineer II works a standard work week but may be required to work some evenings and weekends to meet the needs of the company.

Physical Requirements

Must be able to type using the keyboard of a computer. Must be able to talk, listen and speak clearly on the telephone. Must be able to lift and carry up to 50 lbs.