Quality Control Technician I - 1st Shift

Solesis•Telford, PA

About The Position

What we are looking for: The Quality Control Technician is responsible for assisting with the development, application, validation, implementation and maintenance of manufacturing and quality management systems associated with compliance to internal procedures and applicable statutory and regulatory standards for products and components. What you will do: Assists in the completion of the following Quality Management documents s: nonconformances, deviations, and Returned Material Authorization (RMA). Responsible for acceptance activities: First Article Inspection Reports, receiving, in-process and final inspections as designated on the Device History Records (DHRs). Performs and documents Corrective and Preventive Actions (CAPA) and Supplier Corrective Action (SCAR) investigations as requested. Acts as lead on assigned CAPAs to develop and drive corrective and preventive actions and closure within prescribed timelines as assigned. Provides support to Operations as needed. Participates in the transition of new customer designed products from R&D to commercial production. Assists with training. Supports FDA inspections, customer and third-party audits as required. May be trained to perform internal quality audits. Performs statistical data analysis utilizing statistical software (Minitab and Excel). Supports development and implementation of methods for sampling, inspection, testing and evaluation of products. Assists in maintenance of Approved Supplier List. Authors documents, specifications, procedures, work instructions, validation protocol/reports, etc. as applicable. Other duties as assigned.

Requirements

Associate degree related to life sciences or equivalent
5 years of experience in a regulated environment (e.g., ISO 13485:2016, 21 CFR Parts 810, 811 and 820) in one of the following functions: Quality Control or Product Development
Hands-on experience with test equipment including the ability to understand the working mechanisms and methodologies
Intermediate to advanced knowledge of MS Office Suite (e.g., Word, Excel)
Self-starter with high attention to detail and ability to work on multiple projects
Strong written and verbal communication skills
Knowledge of quality management standards, specifically ISO 13485:2016 and FDA Regulations 21 CFR Parts 210, 211 and 820
Able to read, analyze, interpret, and respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community
Strong problem solving and analytical skills, with concentration on risk analysis (ISO 14971:2019)
Demonstrated project organizational skills required
Ability to apply principles of scientific thinking to a wide range of intellectual and practical problems; deal with nonverbal symbolism (e.g., formulas, scientific equations, graphs); deal with a variety of abstract and concrete variables
Demonstrated ability to participate in and/or lead cross functional teams, ability to independently prioritize and execute projects and responsibilities
Excellent customer service focus and professionalism

Responsibilities

Assists in the completion of Quality Management documents: nonconformances, deviations, and Returned Material Authorization (RMA)
Responsible for acceptance activities: First Article Inspection Reports, receiving, in-process and final inspections as designated on the Device History Records (DHRs)
Performs and documents Corrective and Preventive Actions (CAPA) and Supplier Corrective Action (SCAR) investigations as requested
Acts as lead on assigned CAPAs to develop and drive corrective and preventive actions and closure within prescribed timelines as assigned
Provides support to Operations as needed
Participates in the transition of new customer designed products from R&D to commercial production
Assists with training
Supports FDA inspections, customer and third-party audits as required
May be trained to perform internal quality audits
Performs statistical data analysis utilizing statistical software (Minitab and Excel)
Supports development and implementation of methods for sampling, inspection, testing and evaluation of products
Assists in maintenance of Approved Supplier List
Authors documents, specifications, procedures, work instructions, validation protocol/reports, etc. as applicable
Other duties as assigned