Cardinal Health Quality Manager, QMS in Milpitas, California
What Quality System Management contributes to Cardinal Health
Quality Systems Management is responsible for the development, deployment and maintenance of controlled documentation and supporting systems.
- Demonstrates knowledge of quality systems.
- Demonstrates a thorough understanding of the relevant regulations, standards and operating procedures.
- Demonstrates an understanding of quality concepts such as: documentation systems, change control and electronic records.
- Works well cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements.
- Bachelors in related field, or equivalent work experience, preferred
- 8+ years experience in related field, preferred
What is expected of you and others at this level
- Manages department operations and supervises professional employees, frontline supervisors and/or business support staff
- Participates in the development of policies and procedures to achieve specific goals
- Ensures employees operate within guidelines
- Decisions have a short term impact on work processes, outcomes, and customers
- Interacts with subordinates, peer customers and suppliers at various management levels may interact with senior management
- Interactions normally involves resolution of issues related to operations and/or projects
- Gains consensus from various parties involved
This position manages all activities associated with supporting and maintaining an effective and compliant Quality Management Systems including the responsibility for accuracy and integrity of the associated systems. The responsibilities of the QMS Manager directly affect the ability of the organization to comply with global medical device regulations. Some of the essential functions of this role include:
- Management of various QMS systems, including :
o Non-conforming Product
o Document Control, PLM, Change Management
o Records Management
- Contribute in development of procedures and practices to optimize and maintain robust QMS system as well as provide optimum customer service to all facilities and stakeholders
- Development and review of monthly, quarterly and annual QMS metrics and summaries for distribution to key senior management
- Participate in preparation and interface for corporate, FDA, and other international regulatory agency audits
- Provide training, guidance and direction to sites for various QMS processes and systems
- Liase with IT department to maintain applicable QMS process and tools and to participate in improvement efforts
- Coach staff to leverage their strengths and develop their functional and managerial skills and attract, select and retain the best people to achieve business goals
- Manage expenses to remain within current budget and assist with development of upcoming budgets
An ideal candidate would have experience with Pilgrim Smartsolve (CAPA, Audit, NC modules), Enovia (document control and product lifecycle) and UL ComplianceWire (training) software. Additionally, experience with class 1-3 medical devices and combination products and a solid working knowledge of FDA, ISO and international medical device regulations is highly desired.
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.