Integrated Medical Systems , is currently offering an exciting opportunity as a QMS Compliance Manager in Cooper City, FL . The QMS Compliance Manager is responsible for establishing, implementing, and managing the Division’s Quality Management System (QMS) in accordance with quality management standards, corporate policies, and regulatory requirements as well as implementing and managing advanced quality planning and process improvement practices.
Experience the pride and prestige of working for an extremely successful company committed to first class service offerings.
- Serves as the Division management representative to ensure compliance with the QMS, corporate policies, and regulatory requirements.
- Manages Division level QMS processes to ensure the achievement of planned results. Ensures Division level QMS processes are established, documented, and maintained in accordance with requirements.
- Monitors the QMS to ensure its continuing suitability, adequacy and effectiveness. Ensures QMS processes are measured and analyzed to improve or maintain their effectiveness. Implements actions necessary to achieve planned results while ensuring the integrity of the QMS is maintained.
- Communicates the importance of meeting customer, statutory and regulatory requirements. Promotes the awareness of regulatory and customer requirements.
- Manages and facilitates the regular review of quality objectives.
- Serves as the liaison with external parties on matters relating to the QMS.
- Determines the type and extent of control to be applied to outsourced processes to maintain conformity to customer, statutory, and regulatory requirements.
- Coordinates with Dir. of QMS & RA all regulatory and customer audits and visits. Ensures Division’s preparedness for scheduled regulatory assessments and audits.
- Chairs management reviews and reports to Senior Management on the performance of the QMS and any need for improvement or need to maintain its effectiveness.
- Monitors key indicators of the QMS for corrective and preventative action required for continuous improvement.
Education and/or Experience
- Bachelor of Science degree from four-year accredited college or university; or six years related experience and/or training; or equivalent combination of education and experience.
- Possess a comprehensive understanding of standards/regulations include: ISO 9001, ISO 13485, and SAE AS9100.
- Experience with advanced quality planning and process improvement techniques, tools, and practices including: Lean manufacturing, PPAP, FMEA, Cpk, and gage R&R studies.
- Experience with problem identification and problem solving skills and able to investigate intricate issues, complete root cause analysis and organize written report of results.
- Able to make arithmetical computations (multiplication, division, percentage calculations, addition, and subtraction).
- Experience with reading and interpreting product specifications and drawing schematics.
- Able to perform general office administrative activities: copying, filing, delivering documents and attending meetings within the facility, etc.
Compensation and Benefits
- IMS offers a competitive benefit package for all eligible employees and their eligible dependents. For more information, please visit the benefits page on our website. http://www.imsready.com/careers/careers_benefits.aspx
Integrated Medical Systems - 23 months ago
IMS was originally founded as a surgical instrument repair provider. Fast-forward 20-plus years and IMS now touches virtually every facet of...