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Posted: Tuesday, May 9, 2017 11:26 AM

Job Description:/h3:
An opportunity for a progressive Quality Assurance Engineer within Medical Devices.
Heres what youll do:
Has extensive working knowledge of current Federal Quality System Regulations and relevant international standards and regulations.
Has the ability to develop and maintain Internal Audit Program in accordance with ISO 13485, QSR, EU AIMDD, and CMDR.
Develop an annual internal audit schedule in accordance with Organization Quality System Procedures.
Conducts internal and external audits as assigned per the approved schedule and directed by the head of quality systems.
Performs additional focused/spot audits as directed by management.
Communicates before, during, and after audits regarding standards and regulatory requirements, audit scope interview time and observations.
Responsible for ensuring that auditees understand observations in relation to standards and regulatory requirements as indicated within Organization Quality Systems
Prepares audit reports and all associated documents as described on the audit procedures and work instructions.
Maintains audit database and ensure update, enhancement and improvement of reporting tools for trending audit results.
Writes detailed reports on effectiveness of the quality system including; strengths, weaknesses, non:compliances to the applicable standards regulations for class III medical device company.
Perform Effectiveness Verification for High and Low Level CAPAs.
Ensures audit findings are fact, relevant, accurate, and value added to the companys quality system implementation.
Ensures timely closing of Internal Audit Findings (IAF) and CAPA through verification of corrective action effectiveness.
Performs trending and analysis based on audit observations and presents to senior management as part of the periodic management review.
Plays a key role in supporting external audits from customers, regulatory agencies and /or any interested third party including preparing all organizational sites for external audits.
Trains other internal auditors and subject matter experts, as necessary, in audit principles and techniques.
Responsible for annual quality system audit training for all personnel.
Other duties as assigned by the head of quality systems.
Heres what youll bring to the organization:
:5:10 years of experience working in a regulated medical device environment with experience conducting quality system audits in accordance with ISO 13485 and QSIT
:Extensive knowledge of statistical techniques and ability interpret trended data and charts
:Ability to analyze, evaluate and report on issues that affect quality system processes such as corrective action implementation and training effectiveness
Requirements:
BS: Engineering, Science or equivalent
Certified Quality Auditor by a recognized BOK such as ASQ CQA

Company Description:/h3:
Recruitment and Placement Strategists

Source: https://www.tiptopjob.com/jobs/66859808_job.asp?source=backpage


• Location: San Fernando Valley, sylmar

• Post ID: 115290988 sanfernandovalley
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