- Act as Quality System Management Representative for multiple sites and / or business units.
- Identify and manage interactions and interdependency of elements within the quality system in a large manufacturing organization.
- Directs the daily activities of the quality organization.
- Directs and implements a Quality Management System that complies with regulatory requirements and business objectives.
- Directs and facilitates individual and group development to prepare others to assume new, and/or increasing levels of, responsibility.
- Develops and maintains good working relationships with functional areas that support product and quality within Highridge Medical
- Develops and manages an annual budget with achievement of profit/loss objectives
- Knowledge and experience with the FDA Quality System Regulations, ISO 13485 Quality System Standard, MDD, CMDR, JPAL and other applicable regulations
- Demonstrated experience in interpreting and applying regulations and standards (ISO, QSR, etc.) for Quality Management Systems that govern manufacturing and distribution of products worldwide.
- Extensive experience with leading regulatory audits and responding to and correcting audit findings.
- Strong understanding of medical device design controls requirements and implementation of risk management and development processes.
- Lead and motivate personnel from varied backgrounds and cultures in local and remote locations.
- Ability to achieve productivity goals without sacrificing quality in a manufacturing environment.
- Understands technical aspects of manufacturing operations as they relate to delivery of product meeting specifications and customers' expectations.
- Computer literacy including Microsoft Office Suite.
- Proven strong oral and written communication and presentation skills.
- B.S. degree preferably in a technical discipline, such as engineering or a physical science (M.S. degree is preferred)
- 10+ years of experience in a position of responsibility for establishing and/or maintaining the quality operations (QA/QC) of a medical device manufacturing organization, or an equivalent combination of education and experience.
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Director of Quality - Westminster, United States - Highridge Medical
Description
HIGHRIDGE Medical creates the world's most innovative spinal solutions across the spectrum from Motion Preservation to MIS to Bone Healing to Core Spine. Working at HIGHRIDGE is not just work. Life at HIGHRIDGE is purpose driven. Every day, you have the privilege of using your talents to demonstrate Confidence in your work and restore Confidence for our patients. Confidence that moves.
In order to make an application, simply read through the following job description and make sure to attach relevant documents.
Job Summary
Responsible for directing the quality assurance processes and ensuring compliance with the FDA Quality System Regulations, ISO 13485 Quality System Standard, MDD, CMDR, JPAL and other applicable regulations. Responsible for implementing key metrics in the quality assurance processes and develop effective strategies to ensure the continuous improvement and effectiveness of the quality system.
Principal Duties and Responsibilities
This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.
Expected Areas of Competence (i.e., knowledge, skills and abilities)
Education/Experience Requirements
Travel Requirements
10% - 15%
Salary Range
$161,000 - $200,000
