Expedite Technology Solutions LLC
US_East | Software Developer - Testing Tools/Automation/Performance _L2
Expedite Technology Solutions LLC, Chicago, Illinois, United States, 60290
Possible 3 Month CTH | No Fees | Do Not Re-Post | Confidential
Skype interview is mandatory please provide the candidates skype ID, VIDEO INTERVIEW IS MANDATORY. NO CPT ALLOWED.
Submit candidates under their legal name and use only *** template Candidate's photo ID IS MANDATORY FOR ALL CANDIDATES EVEN CITIZENS.
In your submission include: Phone #: Email address: Location (City and State): Relocate: Availability to start: Visa type and expiration date: Hiring Status: C2C/W2/1099QOpen for CTH (y/n): Timeslots for Skype interview (provide Skype ID) Due to additional onboarding requirements, a meet and greet is required for all new hires. Candidates must be willing to go to the closest ***, Client, or offsite location as indicated by project team to meet with a *** team member prior to starting their assignment. If the candidate is not local, travel will be required at the expense of the *** project team (will receive project code for vendor to submit invoices in SAP Fieldglass for reimbursement). If travel is involved, will send travel policy document for the candidate to adhere to
Vendors: If your candidate is selected for interview, you need to take screenshot of candidate and interviewer once interview is initiated. THIS IS NOW MANDATORY FOR ALL INTERVIEWS to confirm candidate is same as person in CV.
Marie Samayoa OBO Tactical Procurement | Procurement *** North America | Guatemala Email: ***
Job Description: Software Test Engineer Client Specific Location: Plymouth, MN 100% work from office
We are seeking a detail-oriented and experienced Manual Testing Engineer to join our team, specializing in the medical domain. The ideal candidate will have hands-on experience in validating healthcare applications, with a strong understanding of NPS (Non-Product Software) validation protocols and compliance standards. You will be responsible for validating the NPS tools, coordinating with the stake holders and offshore team, formal documentation, protocol creation and execution, requirement traceability.
Key Responsibilities:
Perform manual testing of Non-Product Software (NPS) used in medical device environments (e.g., document management systems, ERP, LIMS, MES). Develop and execute test plans, test cases, and validation protocols in accordance with regulatory and quality requirements. Conduct NPS validation activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Ensure traceability of requirements through RTM (Requirement Traceability Matrix). Collaborate with QA, IT, and business stakeholders to ensure software meets intended use and compliance standards. Document and manage defects using tools like JIRA, Client ALM, or similar. Support audits and inspections by providing validation documentation and evidence. Maintain detailed records of testing activities and validation deliverables.
Required Skills & Qualifications:
Bachelor's degree in engineering, Computer Science, Life Sciences, or related field. 5+ years of experience in manual testing within the medical device or healthcare domain. Experience in NPS validation and understanding of software validation lifecycle. Strong documentation and communication skills. Ability to work independently in an onsite setup and coordinate with cross-functional teams.
Preferred Qualifications:
Experience with quality systems software (e.g., TrackWise, MasterControl, SAP). Knowledge of FDA 21 CFR Part 11, ISO 14971, and ISO 13485. ISTQB or equivalent QA certification. Exposure to risk-based validation approaches.
Submit candidates under their legal name and use only *** template Candidate's photo ID IS MANDATORY FOR ALL CANDIDATES EVEN CITIZENS.
In your submission include: Phone #: Email address: Location (City and State): Relocate: Availability to start: Visa type and expiration date: Hiring Status: C2C/W2/1099QOpen for CTH (y/n): Timeslots for Skype interview (provide Skype ID) Due to additional onboarding requirements, a meet and greet is required for all new hires. Candidates must be willing to go to the closest ***, Client, or offsite location as indicated by project team to meet with a *** team member prior to starting their assignment. If the candidate is not local, travel will be required at the expense of the *** project team (will receive project code for vendor to submit invoices in SAP Fieldglass for reimbursement). If travel is involved, will send travel policy document for the candidate to adhere to
Vendors: If your candidate is selected for interview, you need to take screenshot of candidate and interviewer once interview is initiated. THIS IS NOW MANDATORY FOR ALL INTERVIEWS to confirm candidate is same as person in CV.
Marie Samayoa OBO Tactical Procurement | Procurement *** North America | Guatemala Email: ***
Job Description: Software Test Engineer Client Specific Location: Plymouth, MN 100% work from office
We are seeking a detail-oriented and experienced Manual Testing Engineer to join our team, specializing in the medical domain. The ideal candidate will have hands-on experience in validating healthcare applications, with a strong understanding of NPS (Non-Product Software) validation protocols and compliance standards. You will be responsible for validating the NPS tools, coordinating with the stake holders and offshore team, formal documentation, protocol creation and execution, requirement traceability.
Key Responsibilities:
Perform manual testing of Non-Product Software (NPS) used in medical device environments (e.g., document management systems, ERP, LIMS, MES). Develop and execute test plans, test cases, and validation protocols in accordance with regulatory and quality requirements. Conduct NPS validation activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Ensure traceability of requirements through RTM (Requirement Traceability Matrix). Collaborate with QA, IT, and business stakeholders to ensure software meets intended use and compliance standards. Document and manage defects using tools like JIRA, Client ALM, or similar. Support audits and inspections by providing validation documentation and evidence. Maintain detailed records of testing activities and validation deliverables.
Required Skills & Qualifications:
Bachelor's degree in engineering, Computer Science, Life Sciences, or related field. 5+ years of experience in manual testing within the medical device or healthcare domain. Experience in NPS validation and understanding of software validation lifecycle. Strong documentation and communication skills. Ability to work independently in an onsite setup and coordinate with cross-functional teams.
Preferred Qualifications:
Experience with quality systems software (e.g., TrackWise, MasterControl, SAP). Knowledge of FDA 21 CFR Part 11, ISO 14971, and ISO 13485. ISTQB or equivalent QA certification. Exposure to risk-based validation approaches.