Medical Supply Chain Workers Eligible For COVID-19 Vaccine on March 22nd

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Quality Engineer

Quality Engineer

Responsibilities


Product Quality

  • Plans and conducts the analysis, inspection, and/or integration of test methods to assure the quality of purchased and assembled components and finished goods.
  • Manages inspection workflow and participates in the assessment of returned products, incoming, in-process and finished goods.
  • Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
  • Utilizes statistical analysis techniques to determine product acceptance and sampling   plans, evaluate process capabilities, and develop tolerance limits.
  • Advises on design changes and their implementation and provides training, tools, and techniques to enable others to achieve quality.
  • Coordinates the documentation review, problem solving and calibration for test equipment.
  • Helps to develop, track and report quality metrics.
  • Drives NCR process including root cause analysis, timely disposition and closure.   Leads and/or participates in MRB meetings, identifies trends and develops and administers technical investigation and corrective action programs to resolve recurring quality problems.


Product Development & Operations

  • Contributes to and participates as a resource in the development and implementation of product test plans including Verification and Validation of products and processes.
  • Serves as a liaison to design, procurement, and manufacturing engineering.
  • Performs standard quality engineering reviews of design documentation, quality records, and supplier documentation for compliance.
  • Works with Operations to identify, analyze, and address supplier quality issues.

Requirements

  • Minimum 5 years’ experience as a Quality Engineer in the medical device industry
    BA/BS degree in science or related technical field.
  • Medical Device Quality System Knowledge Including 21 CFR Part 820 (QSR) & ISO 13485.
  • Demonstrated skills in statistical analysis.
  • Strong computer skills.
  • Individual must have a hands-on approach, and succinct communication skills.
  • Experience participating in internal and external audits (e.g., FDA, Notified Body, Supplier).
  • Strong organizational and time management skills.
  • Experience with CAPA, , and risk management.
  • Experience with complaint investigation and field action preferred.
  • CQE, preferred.

Additional Info

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