VTI Life Sciences

Life sciences validation and qualification services

Quality Engineer - Medical Device

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

ContractPendleton, SC, USANo salary listedIn-person

About the Job

Requirements

A minimum bachelor's degree in Life Sciences, Computer Science, Engineering, or a related discipline is required.
At least 2 years of experience in the GMP-regulated medical device industry is required.
Hands-on experience writing and executing validation protocols is required.
Strong technical writing and documentation skills are required.
The candidate must have organizational and project coordination abilities.
The candidate must be able to communicate effectively with multidisciplinary IT teams.
The candidate must be detail-oriented and maintain a strong compliance mindset.
The candidate must be able 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, including laser marking and laser welding.
Review equipment validation protocols (IQ, OQ, PQ) and reports for equipment used to manufacture medical devices, including metal instruments and implants and ABS/PEEK instruments and implants.
Execute validation protocols for manufacturing equipment such as laser marking equipment, laser welders, and grinders.
Compile executed validation packages.
Support standard operating procedure (SOP) development.
Perform and assist with validation activities, including standard operating procedures, work instructions, forms, and templates.
Lead and write deviation investigations related to validations, or assist with non-conformance and corrective and preventive action (CAPA) investigations.

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

About the Company

VTI Life Sciences

Life sciences validation and qualification services

VTI Life Sciences provides validation and compliance services across the pharmaceutical and biotech sectors. They offer a full range of services including computer validation, cleaning validation, process validation, clean room certification, temperature mapping, and qualification of processes, equipment, and facilities. Their work involves conducting and documenting tests, audits, and qualifications to show a facility and its systems meet regulatory standards and quality requirements. The company differentiates itself through its ISO 9001:2000 certification, a commitment to quality, personalized support, and a network of offices in San Diego, San Francisco, Boston, and China that enable broad client coverage. The overall goal is to help clients ensure their operations and facilities comply with industry regulations and operate reliably and safely.

Company size: 51-200
Company stage: Not listed
Total funding: Not listed
Headquarters: San Diego, CA
Founded: 1998

Recently Posted Jobs

Explore more opportunities at VTI Life Sciences

See more jobs