25d ago

Quality Engineer - Medical Device - Contract

EngineeringQuality Engineer

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Quick Summary

Key Responsibilities

SOP, Work instruction, forms, templates. Lead and write deviation investigations related to validations or assist in non-conformances/CAPA investigations.REQUIRED

Technical Tools

EngineeringQuality Engineer

Quality Engineer – Medical Device -Contract
VTI Life Sciences (VTI) is seeking a forward-thinking and ambitious Medical Device Quality Engineer looking to accelerate their careers in the pharmaceutical, biotechnology, and medical device industries. We offer an opportunity to support our teams of industry subject matter experts and thought leaders while consulting with leading companies in the Life Sciences industry.
The successful candidate will lead and coordinate validation execution activities with operations and engineering teams for special processes.

PROJECT OVERVIEW

Location: Pendleton, SC
Start date: Monday, November 2nd
Length of Project: Approximately 4 months
Employment Classification: Contract
Inspecting, Review Protocols, Support, SOP Development, Feedback, Execution
Equipment: Grinders, Laser Welders

KEY RESPONSIBILITIES

Lead and coordinate validation execution activities with operations and engineering teams for special process related areas (Laser marking, Laser welding).
Review equipment validation protocols (IQ, OQ, PQ) and reports for equipment used for manufacturing medical devices such as metal instruments/ implants, ABS/Peek instruments/implants.
Execute validation protocols for manufacturing equipment such as Laser marking, Laser welding, grinders
Compile executed validation packages.
Support SOP development
Perform and assist in any validation activities but not limited to: SOP, Work instruction, forms, templates.
Lead and write deviation investigations related to validations or assist in non-conformances/CAPA investigations.

REQUIRED QUALIFICATIONS
Education

Minimum Bachelor’s degree in Life Sciences, Computer Science, Engineering, or a related discipline.

Experience

Minimum 2+ years of experience in GMP-regulated Medical Device industry
Hands-on experience writing and executing validation protocols

Key Competencies

Strong technical writing and documentation skills
Excellent organizational and project coordination abilities
Ability to communicate effectively with multi-disciplinary IT teams
Detail-oriented with strong compliance mindset
Ability to manage multiple priorities in a fast-paced environment

VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries. VTI offers professional development, training, competitive compensation, excellent benefits, a matching 401K, plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.
As one of the leading global Commissioning, Qualification and Validation Services organizations, VTI is always looking for innovative, talented and experienced validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees. www.validation.org