InSound Medical is a mature startup that is developing a leading edge hearing solution. We are in the final stages of our clinical trials and moving into the launch phase of product delivery. We are looking for a seasoned QA Manager who is eager to join us in this next step.
SUMMARY: Implement and maintain company ISO 13485:2003 Quality Management System and 21 CFR Part 820 FDA Quality System Regulations. Oversee Engineering Services and Quality Engineering functions. Perform Management Representative functions including interfacing site audits with FDA and the notified body. The QA manager is responsible for the quality management system and monitors and advises on how the system is performing. This often includes the publication of metrics depicting regarding company performance against set parameters.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
· Develops and executes quality strategies and systems to comply with Good Manufacturing Practices and all other regulations.
· Serves as the company representative for FDA and ISO 9000 inspections and audits.
· Responsible for directing Engineering Services activities including Document Change Order Processes
· Responsible for accurate Device Master Records; and maintenance of related compliance documentation (e.g. Design History File/Device History records)
· Maintain applicable department standard operating procedures
· Oversee effective/efficient use of database to provide process/system metrics
· Maintenance of company-wide QMS training
· Aid in the generation and implementation of the company’s FMEA and/or Risk management requirements
· Lead Internal Auditing; CAPA; Management Review; Nonconforming Material Review; and Continuous Improvement activities
· Leadership role in obtaining ISO 13485:2003 certification and meeting FDA QSR
· Lead Inspection/Supplier Certification/Process Validation activities
· Responsible for calibration and equipment maintenance
· Active participation in Safety Committee activities
· Experience in Statistical Techniques
REQUIREMENTS:
· Demonstrated working experience of ISO 13485:2003 QMS and FDA Quality System Regulations
· FDA and ISO audit experience
· Knowledge of statistical analysis and continuous improvement techniques
· Knowledgeable regarding documentation compliance requirements for FDA and ISO 13485:2003
· A BS engineering degree or equivalent experience
· Excellent oral/written communication skills
· Strong organization/planning skills
· Working knowledge of FMEA and/or ISO 14971 Risk Management
· Miniature parts inspection and/or design experience
· 5+ years of progressive experience in Medical Device Quality-Regulatory
InSound Medical offers health/dental/vision/vacation/FSA/401k
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