Sr. Quality Engineer Zonare Medical Systems
THIS JOB HAS EXPIRED JOB SUMMARY:
The Sr. Quality Engineer will establish and maintain quality engineering methodologies, systems and practices which meet ZONARE, customer and regulatory requirements. The QE serves as a Quality representative to improve awareness, visibility and communication on quality initiatives to support departmental, functional, site and corporate quality goals and priorities. A successful QE must be hands-on, self-starting, team player; have strong leadership and project management skills, problem solving skills, ability to work under minimum supervision, and communicate effectively with all levels of the organization.
Specific Duties and Responsibilities:
Provides Quality Engineering support and direction to manufacturing and development teams throughout product development cycle, identifies/ coordinates quality engineering deliverables as required by regulation and internal procedures.
Maintains and updates, as necessary, company risk management process to ensure compliance with ISO 14971, EN 62366, EN 62304, IEC 60601 and other applicable risk management standards and drives activities associated with compliance to these standards and internal procedure(s).
Prepares and executes product/ project quality plans, as required.
Supports quality department initiatives and systems including complaint handling, CAPA, internal audits, supplier management, etc, as needed.
Writes and revises Standards Operating Procedures (SOPs), Work Instructions (WIs), Forms, Templates, etc., in accordance with business and regulatory compliance standards.
Prepares for, participates in and responds to regulatory agency and notified body audits
- Indicates Essential Function
Minimum Education: B.S. in Engineering or other technical degree
Minimum 5+ years? experience in medical device industry
Experience in managing the following standards/ requirements:
ISO 1348:2003 Medical Devices ? Quality Management System
US FDA CFR21Part820 (QSR)
ISO 14971:2009 Medical Devices ? Application of Risk Management to Medical Devices
EN 60601-1 Electrical Medical Equipment series
EN 62366 Usability
EN 62304 Software Development Life Cycle
Individual must be motivated to work independently as well as with teams. He or she must be able to manage multiple tasks and prioritize appropriately. Must be detail oriented with good written, verbal and organizational skills. PC skills including use of Windows Operating systems and MS office applications are required.
General office environment. Work is generally sedentary in nature, but may require standing and walking for up to 10% of the time. There are no hazardous or unpleasant conditions caused by noise, dust, etc. Work is generally performed within an office environment, with standard office equipment available. Travel up to 10%.
This position profile identifies the key responsibilities and expectations for performance. It cannot encompass all specific job tasks that an employee may be required to perform. Employees are required to follow any other job related instructions and perform job related duties as may be reasonably assigned by his/her supervisor.
||420 North Bernardo Avenue |
Mountain View, CA 94043
THIS JOB HAS EXPIRED