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Lead Quality Engineer - Wipes
Ref No.: 19-11242
Location: Neenah, Wisconsin
Our client, a leading fortune company is looking for a Lead Quality Engineer - Wipes. This is for an initial duration of 6 months and is located in Neenah, WI

Responsibilities:
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
  • Acts as the owner of one or more critical/high-risk quality systems (Change Control, Design Change Control, Process Change Control, System Change Control) making decisions on changes to standards, auditing system users (including Quality, R&E Mills, and other Enterprise functions) for compliance to standard, training users on the standard, and supporting targeted implementation as needed to deliver business results
  • Identifies need for, develops, and executes continuous improvement plans for assigned systems
  • Takes leadership of, or supports, the development and deployment of strategic quality management plans, initiatives and measures which generally have significant Enterprise-wide scope and impact
  • 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 Client requirements and external laws and regulations
  • General knowledge and experience of Quality Management application within other functions such as R&E, Procurement and Distribution
  • 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 Client Leadership Behaviors
Qualifications:
  • Education
    • A Bachelor's Degree in a relevant field, typically science or engineering-related
  • Experience
    • 10+ years of quality management experience

Skills
  • Regulation 21 CFR Part 820, Part 803 and applicable international quality standards and regulations including ISO 13485:2016, Canadian MDR, and EU Medical Device Regulation
  • In-depth knowledge of applicable Global regulatory compliance requirements for drugs, cosmetics, biocides, and medical devices, including USFDA, Health Canada, TGA is desired. Knowledge and experience with ISO 13485 and ISO 9001 requirements is required
  • 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
  • Strong analytical skills including trend and statistical analysis, interpersonal, and management skills
  • Expert understanding and application of appropriate medical device regulations, requirements and standards
  • 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

Travel: Up to 20% domestic travel

Qualified candidates please send your word format updated resume at the earliest to sangeeth.k@sunrisesys.com.  Thank You.