Quality Validation Engineer II

Company: PDS Tech, Inc.
Location: Grand Island
Posted on: May 5, 2021

Job Description:

PDS Tech, Inc. is seeking a Quality Validation Engineer in Grand Island, NY. Key Objectives of the role:

• To develop and execute the activities related to the validation and re-qualification of equipment, processes, packaging and/or systems used in the manufacture and testing of cGMP products.
• Solves problems in complicated situations using analytical and creative thinking skills.
• Evaluate and find mitigation for the potential risks that may be involved in a projected activity or undertaking.
• Completes assignments of diverse scope and complexity.
• Provides constructive input to team members.
• Supports complex, cross-functional quality investigations in a variety of subject matter areas (e.g. electrical, mechanical, chemistry and computer systems/software) to determine root cause and corrective action.
• Conducts advanced data analyses to determine quality problems and to identify larger scale quality improvements.
• Participates in cross functional team projects (R&D, Mfg, Vendors, etc). Examples: support new product introduction projects or quality improvement projects. Minimum Qualifications (must have):
  • 3 years experience within the Medical Device or Pharmaceutical Industry supporting the manufacture of Regulated Products Knowledge of:
    • Validation in a FDA Regulated Environment
    • Quality standards (e.g., 21 CFR Part 820, ISO 13485)
    • Quality tools (e.g. FMEA, Risk Analysis, Root Cause Analysis)
    • Computer Systems (e.g. TrackWise, AGILE, SAP) Proficient in:
      • Computer applications and current software (Microsoft Excel, Outlook, Word, Access, Project)
      • Technical writingPDS Tech, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Founded in 1977, PDS Tech, Inc. is one of the nation's premier specialty staffing firms with 31 offices nationwide. We offer a full range of benefits including:
        • Health insurance
        • Paid holidays
        • Weekly payroll
        • Immediate 401(k) eligibility
        • Completion Bonuses
        • Training
        • Please note availability of benefits may vary by position PDS specializes in Engineering and IT arenas including Aerospace, Defense, Electronics, Telecommunications, Automotive, and Energy just to name a few. Our reputation, track record, and years of continuous growth reflect the commitment to quality that our employees and clients experience first-hand. To find out more about PDS, please visit $$$ PDS pays for referrals! $$$

Keywords: PDS Tech, Inc., Buffalo , Quality Validation Engineer II, Engineering , Grand Island, New York