Quality Assurance Inspector

Clearwater, FL

Posted: 08/13/2019 Industry: QA/QC Inspector Job Number: JN -082019-11042
Quality Assurance Inspector-Medical Device

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
  • Location: Clearwater, FL
  • Industry: Medical Device
  • Shift: M-F, 6:00AM-2:30PM
  • Salary: $15.00 /hour with bonuses when you go permanent
  • Employment Type: 3-6 month Contract with possible extension
Environment: This customer has a culture of empowerment where team members are trusted with responsibility and decision making. Everyone is expected to take initiative and help when their skills are needed while demonstrating leadership and teamwork. Wouldn t you want to work for a company like that?!


SUMMARY:
  • Perform routine dimensional, visual, and/or functional inspections of raw materials received, in-process product, and finished goods to ensure quality compliance to defined specification and/or the associated Device History Record (DHR).
  • Accurately interpret inspection procedures, test methods, and inspection standards to ensure product and raw materials meet defined specifications.
  • Ability to use mechanical and electronic test equipment and analyze results based on established product specifications.
  • Ability to read and interpret drawings and technical specifications.
  • Generate nonconformance reports. Ensure all non-conforming materials are properly segregated (quarantined).
  • Inspection of product returns, as applicable, and decontaminate, if necessary.
  • Complete all functions in performing Quality release of sterile loads in a timely manner.
  • Review Device History Records (DHRs) and other quality-related documents for accuracy and completeness.
  • Complete Engineering Change Notices (ECNs) to improve and maintain the Quality Management System documentation, as identified, including writing procedures, updating specification, etc.
  • Support Business and quality team during regulatory and customer audits.
  • Assist and/or train staff to support the Quality Management Systems, as needed.
  • Prioritize and manage daily and weekly tasks.
  • Perform and assess routine environmental monitoring of controlled areas per procedure, including monthly metrics, and out-of-specification condition notifications.
  • Interface with all departments, as needed, to ensure compliance, to relay quality concerns, and other associated quality issues.
  • Assist Quality Engineering Manager with special projects and other duties, as assigned. requested.

EDUCATION AND EXPERIENCE:
  • High School Diploma or GED.
  • Experience in using test equipment and measurement tools to interpret the data s outcome.
  • Knowledge of 21 CFR Part 820, ISO 13485, MDSAP, MDD 93/42/EEC is a plus.

CRITICAL COMPETENCIES:
  • Strong problem-solving skills. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret technical instructions in mathematical or diagram for and deal with several abstract and concrete variables.
  • Detail-orientated, thoroughness, and dealing with complexity.
  • Proficient in MS Office (Word, Excel, PowerPoint).

QUALITY ASSURANCE RESPONSIBILITIES: The individual must comply with the following quality system requirements, including, but not limited to:
  • Use only formally approved procedures, records, documents, and specifications, known as Control Documents , such as procedures, records, documents, and specifications, DHRs, etc
  • Use only properly calibrated and maintained equipment.
  • Immediately bring to attention of the Quality Engineering Manager any possible deviations from specified Standard Operating Procedures or Work Instructions.
  • Ensure no components, parts, manufacturing materials, or products are released, unless inspection and test criteria is met.
  • Follow all Standard Operating Procedures and Work Instructions related to the functions performed.Ensure all purchasing documents are completed to Work Instructions.
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