PDS Tech Inc Quality Engineer in Madison, Wisconsin
Job Title: Senior Quality Engineer
Provides high-level Quality/Regulatory leadership for assigned critical and complex quality systems, routinely checking for compliance with standards, and providing training and coaching 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 execution and guidance for one or more critical/high-risk quality systems (Change Control, Design Change Control, Corrective and Preventive Actions, Quality Non-Conformance), ensures compliance to quality systems and supports implementation as needed to deliver business results
Identifies need for, develops, and executes continuous improvement plans for assigned systems
Works with BU and Regional Quality Leaders or Function Leaders such as Contract Manufacturing, as required to build capability at all levels of the organization to ensure sustainable quality results.
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, statistical quality control, product testing and internal quality auditing
Ensures that established manufacturing inspection, sampling, and statistical process control procedures are followed as applicable
Leads or supports assessments of required facilities, functions and suppliers to provide an independent and expert viewpoint. Uses the assessment process to build capability, drive continuous improvement, mitigate risks and ensure compliance to K-C requirements and external laws and regulations
Provides Design Change Control support to Project and Brand Quality Teams, as assigned
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
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
Strong analytical skills including trend and statistical analysis
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 and ISO 9001, and Regulation 21 CFR Part 820, Part 803)
Project Management (development of project plans, status meetings, project reporting, etc.) and organizational change management
Cross functional team experience
General knowledge and experience of Quality Management application within other functions such as R&E, Procurement and Distribution
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
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.