Sr. Quality Engineer -- Medical Device
NO SUBCONTRACT REQUIREMENT:
No third-party applicants will be considered. If you are a third party contracting company, please do not respond to this position.
Provides high-level Quality/Regulatory leadership for assigned critical and complex quality systems, developing and improving those systems to deliver business results, routinely checking for compliance with standards, and providing training to customers/stakeholders.
Operations, Regulatory Affairs, Product Safety, Research & Engineering, Packaging, Planning, Procurement, Legal, Marketing, Communications, Plants, Contract Manufacturers, Regulatory Agencies,
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
- Provides technical expertise and leadership for the risk management system to ensure compliance with regulatory and internal requirements and consistency
- Partners with the system owner and users to drive continuous improvement for an effective risk management system.
- Develops and maintains risk management files in accordance with medical device industry regulations and internal requirements
- Provides risk management training and guidance to all applicable departments
- Facilitates development and completion of product and process risk assessments
- Serves as the risk management Subject Matter Expert supporting cross-functional project teams as assigned
- Takes leadership of, or supports the development and deployment of strategic quality management plans, initiatives and measures
- Direct experience of quality management within a manufacturing environment is highly desirable, demonstrating an understanding of major quality management processes and practices such as GMP standards, HACCP, Risk Management, statistical quality control, product testing and internal quality auditing
- General knowledge and experience of Quality Management application within other functions such as R&E, Procurement and Distribution
- Initiates and follows up on CAPA and QNC related to the assigned systems
- May lead or support the implementation of medium to large business initiatives
- Provides practical solutions and advice to any issues observed
- Manages self in accordance with the One KC Leadership Behaviors
- A Bachelor' s Degree in a relevant field, typically science or engineering-related
- Formal risk management training by a recognized institution is desired.Experience
8 years of broad experience in a Quality, Manufacturing, Research, or Regulatory function
- Six Sigma Certified Black or Green Belt, ASQ-Certified Quality Engineer, Certified Quality Auditor, Certified Quality Manager and ISO 9001 or 13485 Lead Auditor Certification is preferred
- Understanding and application of appropriate medical device regulations, requirements and standards (including USFDA, Health Canada, TGA) as well as knowledge and experience with ISO 13485, ISO 14971, ISO 9001, and Regulation 21 CFR Part 820, Part 803
- Experience leading the development and maintenance of Design and Use FMEA' s and Process FMEA' s in medical devices is desired
- Experience in the creation and maintenance of risk management files in accordance with medical device regulatory requirements is desired
- Project Management (development of project plans, status meetings, project reporting, etc.) and organizational change management
- Cross functional team experience
- Communication in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor
- Manage time working on multiple projects simultaneously
Director of Business Development
John is currently the Director of Business Development for Contract Professionals, Inc. He currently manages the Green Bay, Wisconsin office and works with clients in Wisconsin, as well as several clients located throughout the United States.
John started his career in talent acquisition in 1998 in Boston, Massachusetts. For the past 20 years, John has worked with clients throughout the U.S. providing contingent and permanent staffing solutions in the areas of engineering, information technology and government/defense related positions.
John works directly with hiring managers and corporate recruiters to understand their staffing goals and future needs, in order to support their hiring initiatives.
In his free time, John enjoys golfing and spending time with his family and their dog “Inky."