Title: Quality Engineer- QMS
Location: Neenah WI 54956
Duration: 12 Months (contract to Hire)
Hours : 8:00am to 5:00pm
- Demonstrate safety as a value by performing all job functions safely, while also complying with corporate policies and departmental procedures, in an effort to reduce risk and eliminate loss.
- Manages self and/or team in accordance with the expected behaviors of the Leadership Qualities. Effectively achieve results that meet business and individual objectives.
- Ensures activities and items are in compliance with both company quality assurance standards and applicable government regulations, such as GMPs and ISO requirements.
- Ensures that established manufacturing inspection, sampling and statistical process control procedures are followed as applicable.
- Performs production and quality systems audits.
- Develops and implements support systems and processes for managing quality records and documents that meet both internal and external requirements.
- Maintain and demonstrate an appropriate level of knowledge and skill in product forms, quality systems, processes, and regulations.
- Establish and maintain good customer rapport, while driving solutions to meet business needs. Develop and maintain a strong spirit of partnership.
- Executes continuous improvement activities for established processes and initiates development of new processes.
- Builds and maintains capability in K-C QMS, Standards, and Regulations (FDA, Health Canada) to support objectives.
Position Specific Accountabilities:
- Act as the system owner of one or more critical/high-risk quality systems (CAPA/QNC, Internal Audits, Audit Readiness), making decisions on changes to standards, auditing system users (including Quality, R&E, Mills, and other enterprise functions) for compliance to standards, training users on the standards, and supporting targeted implementation as needed to deliver business results.
- Identifies need for, develops, and executes continuous improvement plans for the assigned systems.
- Builds and maintains capability within the assigned systems for compliance with K-C QMS, Industry Standards, and Regulations.
- Initiates and executes continuous improvement activities for established processes, and supports development of new processes.
- Provides Quality System technical expertise and/or support to business, suppliers and other functional teams.
- Assists in the development and implementation of new quality concepts to improve the way business, facilities, and support functions perform duties to achieve Quality objectives.
- Initiates and follows up on CAPA and QNC related to the assigned systems.
- This position reports to NA Sr. Quality Manager. Has responsibility for assigned customers as well as assisting with other customers. Assists in or leads moderate to large sized projects. Plans and carries out customer service and project responsibilities with minimal direction but asks for assistance/guidance when appropriate.
- Qualifications/Education/Experience Required:
- Normally requires a bachelor’s degree in science, engineering or related discipline and 8+ years of broad experience in a Quality, Manufacturing, Research or Regulatory function. Experience should include close working relationships with customer functions, good breadth of knowledge of applicable FDA, Health Canada, and K-C QMS requirements for formulated cosmetics and medical devices, technical quality skills in the applicable or related system area, demonstrated application of LEAN/ Continuous Improvement skills, and demonstrated skill as a trainer. Requires prior leadership experience with moderate to large sized projects or systems.
- 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.