Quality Engineer - Medical Device - Contract

VTI Life Sciences; Pendleton (SC); On-site; USD 55,000 - 83,000; Part time

Job summary

VTI Life Sciences, Pendleton, SC, seeks a Medical Device Quality Engineer (Contract) to lead validation activities for laser marking/welding and other special processes. You will review IQ/OQ/PQ protocols, compile validation packages, and assist in SOP development.

Requires a Bachelor’s in Life Sciences/Engineering and 2+ years in GMP-regulated medical devices, with strong writing, organization, and cross-disciplinary communication skills. Project duration ~4 months.

Qualifications

• Bachelor’s degree in Life Sciences, Computer Science, Engineering, or related discipline.
• 2+ years of experience in GMP-regulated Medical Device industry.
• Hands-on experience writing and executing validation protocols.
• 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.

Responsibilities

• Lead and coordinate validation execution activities with operations and engineering teams for special process areas (Laser marking, Laser welding).
• Review equipment validation protocols (IQ, OQ, PQ) and reports 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.
• Lead and write deviation investigations related to validations or assist in non-conformances/CAPA investigations.

Skills

Technical writing

Documentation

Project coordination

Multidisciplinary communication

Detail oriented

Education

Bachelor’s degree

Job description

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