Quality Validation Engineer (Medical Device )

Niagara Univ, New York
Apr 20, 2021
May 05, 2021
Organization Type
Quality Validation Engineer (Medical Device )

Pay rate -45$/hour

Duration- 6 months W2 contract with potential extension

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 writing

Why Kelly ® ?

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly® Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we're here every step of the way to find your dream engineering job.

About Kelly ®

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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