Quality System Compliance Specialist Zonare Medical Systems
THIS JOB HAS EXPIRED Department: Regulatory and Quality
FLSA Status: Non Exempt
Reports To: Director of Regulatory and Quality
The Quality System Compliance Specialist will develop and support internal Quality Systems to meet various ISO standards, regulatory and customer requirements. The QS Compliance Specialist will drive activities including maintenance of the Compliant Handling and reportability. The QS compliance specialist shall be responsible for ZONARE?s Document Control system, Periodic QS Procedural Review and Quality System records/ regulatory files. The QS compliance specialist shall support management review, supplier business reviews, metric reviews and analysis of data. A successful QS compliance Specialist 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:
Supporting Complaint Handling and Reportability processes by assessing escalated service calls for complaints, completing and distributing complaint reports, complaint investigations and reportability assessments.
Leads Change Management (ECO) process for company including periodic review of ZONARE?s quality system procedures.
Ensures compliance to the regulations/standards listed under Qualifications below
Prepares for, participates in and responds to regulatory agency and notified body audits
Assists Quality Department in conducting quality performance measurements including developing, tracking, and publishing metrics, ensuring company awareness of regulatory and customer requirements and preparing for and presenting to management team on the performance of the quality system.
Writing and revising Standards Operating Procedures (SOPs), Work Instructions (WIs), Forms, Templates, etc., in accordance with business and regulatory compliance standards
B.S. in Science, Engineering or equivalent combination of education and experience
Minimum 5+ years? experience in medical device industry
Experience in managing the following standards/ requirements:
SO 1348:2003 Medical Devices ? Quality Management SystemUS FDA CFR21Part820 (QSR)
ISO 14971:2009 Medical Devices ? Application of Risk Management to Medical Devices
ISO 13485:2003 Lead Auditor Certification and/or ASQ Quality Auditor a plus.
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%.
||420 North Bernardo Avenue |
Mountain View, CA 94043
THIS JOB HAS EXPIRED