Hope you are doing well.
We have an immediate opening for Software Quality Assurance Engineer/Analyst Please go through the below requirement and send me your updated resume to akil@globalpharmatek.com or please call me on 732- 228-4115 to discuss more about this position.
Title : Software Quality Assurance Engineer/Analyst
Location : Ann Arbor, MI
Duration : 6+ Months
Responsibilities would be to review the product software design documentation and make sure they adhere to the regulations and requirements. They must be the type of individual who can work cross functionally with electrical engineers, mechanical, system and regulatory.
Day to Day: The SQA Engineer will assist the Robotics team in developing the software for the Medical Device Robotic Products. Involves - Quality Assurance activities, reviewing Design Documents, enforcing Quality System standards, and collaborating with the Software Development team to address issues.
Requirements
1. Medical Device or Pharma experience
2. Minimum of 2+ years of Software Quality Assurance experience
3. Collaborative team player, but who can also enforce the regulations/rules when needed
4. Product lifecycle experience
Preferred (but not necessary)
· PTC Integrity or similar Software System Lifecycle Management (SSLM) exposure.
· ASQ certification
· Exposure to ISO 13485, IEC 62304, IEC 60601
· Exposure to robotics or electrical devices
Additional Notes: Doesn’t need to be able to write software code but must be able to review/read software code to ensure compliance to regulatory requirements.
Thanks & Regards,
Akil R
15 Corporate Place S, Suite 345, Piscataway, New Jersey - 08854
US Tel : 732-543-7155 Ext.: 9055 | US Direct: 732- 228-4115 | Fax : 732-474-0144
akil@globalpharmatek.com | www.globalpharmatek.com
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