Quality Engineer

4 weeks ago

Hayward, United States inSync Staffing Full time

Quality Engineer

Location: Hayward, CA - Hybrid

Pay Rate:​ $34.25-$42.75/hr

Duration: 6 months+

Hours: 9am-5pm. Mon-Fri



JOB DESCRIPTION

  • 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
  • All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.


Education:

  • Bachelor’s degree, ideally in an engineering discipline


Benefits:(employee contribution)

 Health insurance

 Health savings account

 Dental insurance

 Vision insurance

 Flexible spending accounts

 Life insurance

 Retirement plan



All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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