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Quality Assurance Engineer
2 months ago
Verista is seeking a highly skilled Quality Assurance Engineer to join our team. As a Quality Assurance Engineer, you will be responsible for ensuring the quality of our products and services, and for implementing and maintaining our quality management system.
Key Responsibilities:
- Manage and work collaboratively with clients' quality representatives to complete deviation investigations and resolutions for problems and issues encountered during execution activities.
- Support clients' change management programs, including authoring proposed changes, executing impact assessments and regression analysis, and supporting client documentation of change results and release.
- Author, edit, and execute technical commissioning, qualification, and validation documentation for standard equipment, systems, and software, and processes as part of a team directed by the project leader.
- Run test scripts and document results.
- Adhere to project schedules for all assigned activities.
- Maintain clear, detailed records of qualification and validation.
- Document impact and risk assessments as part of a team.
- Complete user interface testing, software verification, and complete alarm testing on automated systems.
- Develop, review, and execute testing documentation.
- Make recommendations for design or process modification based on test results when executing test scripts.
- Read technical schematics to identify, locate, and test photo sensors, verify part numbers, and complete I/O testing on automated manufacturing equipment.
- General understanding of capital equipment implementation and process knowledge.
- Understanding validation documents, URS, IQ, OQ, PQ.
- Verify system drawings, including reviewing and as-built P&IDs (piping and instrumentation drawings) and I&C (instrumentation and controls) drawings, as well as verifying electrical schematics with support of an electrical engineer.
Requirements:
- Must be willing to work onsite in Fishers, IN.
- Bachelor's Degree or equivalent required (STEM degree, Biomedical Engineering, Chemical Engineering preferred).
- 2-4 years of relevant industry experience.
- Proficiency using PC and Microsoft Office tools.
- Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms.
- Ability to work as part of a team.
- Strong problem-solving and critical thinking skills.
- Excellent organizational and time management skills.
- Strong attention to detail.
- GMP and Good Documentation Practice training (may be completed at onboarding).
- Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes).
- Basic skills with EXCEL and PowerPoint.
- Strong interpersonal skills and clear communication capabilities.
Benefits:
Why Choose Verista?
- High growth potential and fast-paced organization with a people-focused culture.
- Competitive pay plus performance-based incentive programs.
- Company-paid Life, Short-Term, and Long-Term Disability Insurance.
- Medical, Dental & Vision insurances.
- FSA, DCARE, Commuter Benefits.
- Supplemental Life, Hospital, Critical Illness and Legal Insurance.
- Health Savings Account.
- 401(k) Retirement Plan (Employer Matching benefit).
- Paid Time Off (Rollover Option) and Holidays.
- As Needed Sick Time.
- Tuition Reimbursement.
- Team Social Activities (We have fun).
- Employee Recognition.
- Employee Referral Program.
- Paid Parental Leave and Bereavement.
For more information about our company, please visit us at our website."}