Quality Engineering | Warsaw, IN | Full Time and Contract
Damco Solutions is a leading IT services, consulting and outsourcing company delivering exceptional business solutions and customer value to its customers worldwide.
Damco offers end-to-end innovative and leading edge solutions to help corporations leverage technologies, outperform their competition and acquire sustainable growth. We have proven capabilities in new and emerging technologies and extensive experience across a broad range of industries and domains which enable us to deliver world-class, secure, scalable and reliable business systems.
Title: Quality Engineer
Location: Warsaw, IN
Duration: Full time
- Strong engineering skills with working knowledge 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 1 years 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 Methods
- 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 Bachelor's degree (Master's 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) is required.
- A strong communication and interpersonal skills is required.
- Ability to work independently and partner with a cross-functional team (R&D, Regulatory, Manufacturing, and Marketing).- Good
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