Redwood City, CA

Quality Assurance Inspector / Medical Devices

Our client, a world-leading Pharmaceutical Company in Redwood City, CA is currently looking for an Quality Assurance Inspector / Medical Devices to join their expanding team.

Position Details:
  • Job Title: Quality Assurance Inspector / Medical Devices
  • Duration: 12 months contract, extendable up to 24 months
  • Location: Redwood City, CA

Note:
  • The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
  • You may participate in the company group medical insurance plan

Job description
  • The Quality Assurance Inspector is responsible to provide general quality assurance support in the areas of inspection, document control and the overall maintenance of the quality management system.
  • This position supports both R&D and Operations through all phases of product lifecycle.
  • The candidate will utilize SAP to document Quality transactions as well as assist in compiling and trending quality data.

Responsibilities:
  • Performs Quality review of documents related to QC testing, receiving inspection and lot history records (LHR) or device history record (DHR) as required.
  • Verifying product meets specifications and provide final quality approval
  • Initiate and process Non-Conforming Material Reports when required and documenting non-conformance to specifications through the completion of required paperwork, SAP system transactions.
  • Understanding of QSR/ISO 13485, 21 CFR 820, GMP environment and document results per GDP standards
  • Supporting and participating in internal and external audits such as Notified Body and FDA as needed.
  • Performs incoming and in-process inspection of products as needed.
  • Assists in developing and implementing effective inspection to verify compliance of product with specifications.
  • Assists in developing inspection requirements and sampling plans for components and performs inspection activities as required.
  • Perform inspections of purchased parts, subassemblies, or finished company products according to specifications or standards using standard physical, mechanical and/ or electrical measurements as needed.
  • Accurately document the results of the inspections and testing in SAP and on data sheets/forms as applicable.
  • Maintaining all controlled document files and test records in a timely and accurate manner.
  • Participate and/or assist in writing and updating inspection procedures, protocol, and checklists.

Qualifications:
  • Minimum HS diploma and practical experience. AA or AS degree preferred.
  • Knowledge of GD&T preferred
  • 3+ years Quality Assurance and Quality Control experience preferred.
  • Working knowledge of the FDA medical device Quality Systems Regulations and international quality system standards QSR/ISO 13485 and 21 CFR 820.
  • Ability to read and comprehend engineering drawings and schematics is preferred.
  • Ability to work independently, prioritize activities and communicate well.
  • Proficient in analytical, written, oral communication skills; and the ability to manage a variety of tasks simultaneously within cross-functional teams under minimal day-to-day supervision.
  • Proficient technical writing skills and use of documentation programs (e.g., Office Windows, Excel, Access, Power Point, etc.).
  • Able to identify and recommend effective solutions to problems, utilizing technical problem-solving tools, working individually and with others within and outside the quality function.
  • Previous experience with SAP preferred
  • Proficient in knowledge of a variety of testing equipment (including Instron, pin gages, snap gages, micrometer, caliper, etc.) is helpful.

Work Environment:
  • This position operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers.

Physical Demands:
  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
  • While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk; use hands to finger, handle or feel; and reach with hands and arms.

Position Type and Expected Hours of Work:
  • This is a full-time position. Days and hours of work are flexible Monday through Friday, generally 8:30 a.m. to 5:30 p.m.
  • Occasional evening and weekend work may be required as job duties demand.

Recommended Skills

  • Engineering Drawings
  • Qc Testing
  • Quality Assurance
  • Quality Control
  • Technical Writings
  • Testing
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