Precision Edge Surgical Products Company LLC ยท 3 hours ago
Validation Engineer
Angola, IN
Full-time
Onsite
Mid LevelPrecision Edge Surgical Products Company LLC is a contract manufacturer of surgical components and cutting tools. They are currently seeking a Validation Engineer to conduct validation activities in compliance with regulatory standards and to develop validation documentation as required.
HardwareManufacturingMedical DeviceRetail
Responsibilities
Conduct validation activities in compliance with Regulatory standards and requirements and Precision Edge Surgical procedures
Develop validation documentation as required (e.g. plans, protocols, reports, procedures)
Execute validation protocols as required (e.g. Equipment IQ/OQ, Process OQ, Process PQ, etc.)
Prioritize qualification activities in line with the project schedule
Coordination, implementation and active participation in the site validation program for product, process, equipment, software, methods, utilities / facilities and cleaning
Provide input into all project phases (i.e. from design through to the commissioning and qualification execution phases of the project)
Assist in the evaluation of the validation statues of contract manufacturers and provide guidance where needed. Review and approval of documents prepared by the validation team, other departments and contractor organizations (e.g. commissioning test plans, impact assessments, change controls)
Resolve and assist in the closure of deviations initiated during qualification / validation execution
Initiate and implement change control activities in accordance with Precision Edge Surgical procedures
Co-ordinate re-validation activities
Generate procedures / other documentation as applicable
Conduct training in validation methodologies and related procedures as required
Qualification
Required
BS in Mechanical or Bio-Medical Engineering Required
Relevant qualifications in science, technology or engineering
Experience / knowledge preference in Medical Device manufacturing, Contract manufacturing and / or Pharmaceutical / Bio-Pharmaceutical
Excellent interpersonal skills
Ability to lift 50 pounds
Excellent communication skills both written and verbal
Self-starter / team player / minimal supervision
Excellent analytical and reporting capabilities
Must be able to plan, organize, and implement multiple concurrent tasks
Blueprint / Engineering schematic reading and interpretation
Intermediate PC skills
Must be willing to work as part of a multi-site team and be able to travel as part of the job
Preferred
Experience in CNC machining processes
Experience in any of the following: six sigma, lean manufacturing, process capability and statistics
Medical Device experience with a high volume-manufacturing environment desirable
Company
Precision Edge Surgical Products Company LLC
Precision Edge is a world-renowned contract manufacturer of fine surgical components, cutting tools and accessories.
Founded in 1989
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase