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Senior Quality Engineer - Process Validation III
Ref No.: 19-11599
Location: Neenah, Wisconsin
Our client, a leading fortune company is looking for a Senior Quality Engineer  - Process Validation III. This is for an initial duration of 4 months and is located in Neenah, WI
 
Manager Notes:
  • Quality System leader for Process validation.
  • Looking for someone with strong experience in Class I and class II medical Devices.
  • Top Skill sets, statistical sampling (applied Statistics) is required. Process validation experience, Six Sigma Black or green belt. FDA regulation 21 CFR 820 and ISO 1345 experience is required.
 Description/Comment:
Location: Neenah, WI
  • Travel: Up to 15% domestic travel
 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.
  • Provides guidance for one or more critical/high-risk quality systems (Process Validation) making decisions on changes to standards, auditing system users (including Quality, R&E, Manufacturing Sites, and other Enterprise functions) for compliance to standard, training users on the standard, and supporting targeted implementation as needed to deliver business results
  • Provides Validation and Process Change Control support to Project Teams and Manufacturing Quality Teams, including writing, reviewing, executing, and approving Validation protocols, as assigned.
  • Initiates and follows up on CAPAs related to the assigned systems
  • 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 for assigned systems
  • Works with Quality Leaders and other Functional Leaders such as Research & Engineering to build Validation-related capability at all levels of the organization to ensure sustainable quality results.
  • 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
  • Ensures that established manufacturing inspection, sampling, and statistical process control procedures are followed, as applicable
  • 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:
  • 8 years of broad experience in a Quality, Manufacturing, Research, or Regulatory function
 
Skills:
  • Six Sigma Certified Black or Green Belt, or ASQ-Certified Quality Engineer Certification is preferred
  • Experience with Design of Experiments (DOE), Process Characterization and Validation, Gage R&R, and Risk Management tools (e.g. FMEA) is required
  • Strong analytical skills including statistical analysis are required
  • Experience with Batch/Blend, Cleaning & Sanitization, and Clean In Place validation to Cosmetic or OTC Drug standards 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 and ISO 9001, and Regulation 21 CFR Part 820, Part 803) is required        
  • Hours:  8:00am to 5:00pm
 
Qualified candidates please send your word format updated resume at the earliest to sangeeth.k@sunrisesys.com.  Thank You.