Sr. Mgr., Quality and Regulatory Compliance  

Location: Salt Lake City, UT, UTAH
Date Posted: 09-02-2016
A motivated individual with strong management skills in the medical device industry is needed to manage the QA operations of our Quality and Compliance group.  Key focal points include compliance, product and process remediation, inspection and audit readiness, CAPA, and Risk Management regulations, ISO 14971 and IEC 60601, and FDA.   This position requires a strong leader capable of being the ‘process owner, manage teams, and be able to coordinating and presenting QA Operations Product and Process Metrics. You will be actively involved in external audits and inspections, Subsystem and Management Reviews, QN Remediation, and management of personnel and projects. Salary base target $130K.  This is a direct hire position with bonus potential and generous benefits.
 
Summary:
  1. Subsystem and Management Reviews-process owner.
  2. QA Operations Product and Process Metrics coordination and presentation
  3. Leadership for QA Ops process improvements and training
  4. Active involvement in external audits and inspections, QN Remediation
  5. Build cross functional organization relationships
  6. Know Risk Management regulations and application (ISO14971)
  7. Product and Process Remediation activities
  8. FDA interactions
  9. Problem Solving
 
Responsibilities:
- Responsible for Quality System Maintenance.
- Root cause analysis and implementation of corrective action for process related concerns.
- Responsible for continual improvement activities to enhance the quality system, such as 5S, Kaizen lean methods, etc.
- Develop training to build quality awareness.
- Interface with Engineering and Operations to ensure transfer to Production of new products are in accordance with approved data.
- Support the Quality Inspectors to ensure that products and processes comply with the relevant requirements of the quality management system.
- Conduct audits, including closing out audit findings, creating audits finding reports and determine proper corrective and preventive actions.
- Analyze failure, corrective and preventive action to respond to customer complaints.
- Responsible for planning, organizing and managing the overall activities of receiving / outgoing quality functions.
- Continuously improving QA receiving inspection process and procedures.
- Ensure timely resolution of supplier failure, corrective actions and preventive actions.
- Manage suppliers’ performance and conduct audits.
- Preparation of QA reports.
 
Job Requirements / Minimum Required Skills and Knowledge:
            Bachelor’s degree and 9 years of related experience.
            Experience managing direct reports
            Experience in medical device manufacturing
            Knowledge and experience with regulatory compliance and risk management – ISO 14971, IEC 60601 preferred
 
Thank you in advance for your interest in this opportunity.
 
Thank you for considering this opportunity!
 
 

 
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