??We are looking for Post Market Surveillance Engineer for our client in Warsaw, IN
Job Title: Post Market Surveillance Engineer
Job Location: Warsaw, IN
Job Type: Contract ? 12 Months / Contract to Hire / Direct Hire
- Strong engineering skills with workingknowledge of Post Market Surveillance activities.
- Execute Post-Market Surveillance process with a primary focus on signal assessment and detailed investigations and reports of potential Safety Issues and Quality Trend Events
- Knowledge of QSR, Design Controls,Material properties and ISO quality requirements.
- A minimum of 1years of related experience is required, preferably within a regulated environment (e.g. FDA regulated).
- Experience in CAPA execution and management, Non- Conformances management.
- Experience in Statistical Techniques and Method
- Ability to use Quality Engineering principles, tools, and practices to develop and optimize systems and processes that are aligned with the overall business and quality vision is required
- Experience in a Medical Device and/or regulated work environment is required.
- Candidates should have a Bachelordegree (Master degree is preferred) in Engineering or Science such as Materials Science, Materials (Metallurgy) Engineering, Mechanical Engineering, or Biomedical Engineering.
- Knowledge of Microsoft Office (Word,Excel, PowerPoint, and Outlook) isrequired
- A strong communication and interpersonal skills is required
- Ability to work independently and partner with a cross-functional team, Regulatory, Manufacturing, and Marketing).