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Quality Engineer I

3 months ago

Hayward, United States Planet Pharma Full time

6-Month Contract

$35-$42/Hour


Responsibilities:

  • Provide key support for management of nonconforming material (NC), RMA and deviations to ensure timely and efficient resolution of manufacturing interruptions and/or component quality issues
  • Develop subject matter expertise in SAP workflows for RMA and NCM handling
  • Executes usage decisions for RMA in line with QMS requirements
  • Verify accuracy and compliance of NC and deviation records
  • Plan and execute all aspects of material containment, including physical and system transactions and management of holds
  • Collaborate as part of cross-functional team to implement process improvements and/or resolve material or process issues
  • Support global project implementations (e.g. with system testing, local stakeholder communications, etc)
  • Ensures adequacy of nonconformance, deviation and CAPA records, investigations, and corrective actions
  • Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making
  • Assist with material inspections as needed
  • Maintain company documentation related to assigned functions (e.g. work instructions, forms)
  • Promote “Zero Defect” mentality throughout the manufacturing process
  • Provide logistics support to external audits
  • Other activities as assigned

Listed responsibilities are an essential but not exhaustive list of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.


Requirements:

  • 0-3+ years’ experience in Quality Assurance supporting manufacturing in a regulated environment (equivalent manufacturing experience with demonstrated Quality mindset may substitute)
  • Experience applying quality regulations and standards (e.g. 21CFR 820, ISO 13485) to actual situations
  • Practical experience with design controls, risk management, validation and/or change control desired
  • Experience with CAPA and failure investigation tools and techniques desired
  • Adaptable to fast-paced, dynamic work environment with shifting demands
  • Must have strong verbal and written communication skills, work well with diverse groups of people and be able to function independently of direct supervision


Education:

Bachelor’s degree, ideally in an engineering discipline