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Quality Engineer - Post Market
Ref No.: 19-11248
Location: Neenah, Wisconsin
Our client, a leading fortune company is looking for a Quality Engineer - Post Market. This is for an initial duration of 6 months and is located in Neenah, WI

Job Description:
General Expectations and Accountabilities:
  • 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 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.
  • 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.
  • Conduct all communications and transactions with the utmost integrity. Communicate fully with superiors, teammates, and others who have a need to know.
  • Executes continuous improvement activities for established processes and initiates/supports development of new processes.
  • Builds and maintains capability in QMS, ISO, and GMPs to support objectives.
  • Work results have the ability to influence longer-term product or functional decisions
  • Requires independent completion of work, where judgment and discretion is required within the boundaries of the Post Market Surveillance end to end process
Position Specific Accountabilities:
  • Execute assigned Post-Market Surveillance activities, including Complaint Assessment, Investigation, Trending/Reporting, Decision Tree Completion, Final Review, and Sample Evaluation. Flow to Work to assist others as needed.
  • Act as the owner of one or more quality sub-systems (within Post-Market Surveillance), making recommendations and decisions on changes to standards, providing training to users, and supporting implementation as needed.
  • Identifies need for, develops, and executes continuous improvement plans for the assigned sub-system(s) to deliver business results.
  • Builds and maintains capability within the assigned sub-system for compliance with QMS, ISO, and FDA GMP's.
  • Responsible for providing Post-Market Surveillance support to assigned Mills and/or Product Forms via Standard Work, data analysis, and communication. Responsible for completing Level 1 & 2 Complaint Investigations on behalf of Mills.
  • Initiates and follows up on CAPA and QNC related to the assigned system.
  • Provide medical insight to assigned brands as well as supporting team requirements for preliminary medical assessment. Align opinions with Product Safety and Senior Medical Officer and escalate as needed.
Qualifications/Education/Experience Required:
  • Normally requires a Bachelor's degree in nursing or related medical discipline or 5+ years broad experience in a medical function. Incumbent should have experience influencing multi-functional teams. Knowledge of Medical Device requirements is desired. Applies in-depth knowledge and skills within the context of a similar industry or type of organization, and may be viewed as a technical/advanced specialist within the Post Market Surveillance team and the end to end complaint handling process.
  • Dimensions:
  • Personnel: Can provide work direction for 0-5 people, depending on role, objective, or project - at manager discretion
  • Travel Expectations:
  • Position may require travel of up to 10% to support business requirements.
Qualified candidates please send your word format updated resume at the earliest to sangeeth.k@sunrisesys.com.  Thank You.