Quality Validation Engineer II
Company: PDS Tech, Inc.
Location: Grand Island
Posted on: May 5, 2021
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
- 3 years experience within the Medical Device or Pharmaceutical
Industry supporting the manufacture of Regulated Products Knowledge
- 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
- 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
- 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
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