Quality Assurance Specialist

Praxis TechnologyQueensbury, NY
8d$26 - $28

About The Position

Reporting to Quality Manager, the Quality Assurance Specialists plays a crucial role in ensuring the production of high-quality products while maintaining and improving our quality management systems to meet regulatory requirements. The ideal candidate must be able to work independently and as a team, have a strong work ethic, a positive attitude, and strong commitment to quality.

Requirements

  • Minimum three (2) years experience working in a Quality Department in a manufacturing environment.
  • Strong analytical and problem-solving skills
  • Familiarity with quality management systems and tools
  • Detail-oriented with a focus on continuous improvement
  • Excellent interpersonal skills, with ability to collaborate with and support all levels of associates
  • Demonstrated ability to assess priority, complete tasks, and work independently
  • Demonstrated verbal and written communication skills, organized and effective technical writing

Nice To Haves

  • Experience within Medical Device, Aerospace Industry, or other regulated industries preferred.
  • Working knowledge of ISO 13485, QSR, GMP, AS9100 (preferred)
  • Experience in writing production, quality and safety procedures and/or qualification protocols and documents (preferred)

Responsibilities

  • Perform root cause investigations of non-conformities and customer complaints; implementing corrective and preventative actions to prevent recurrence.
  • Support Corrective and Preventive Actions (CAPA) to continuously improve the quality management system.
  • Maintain the computerized maintenance management system by entering new equipment and equipment changes.
  • Support the calibration program by ensuring timely completion calibrations.
  • Create and implement effective quality controls by establishing monitoring, sampling, and inspection methods.
  • Lead and participate in the development and implementation of quality systems, records, and procedures to ensure compliance with applicable regulatory requirements, standards, and company policies.
  • Support internal audits to assess the effectiveness of the quality management systems.
  • Conduct regular inspections and audits to identify defects, deviations, or non-compliance issues.
  • Provide training and support to employees to ensure adherence to quality standards.
  • Support external audits from regulatory bodies and customers.
  • Identify, champion and support continuous improvement projects in quality, productivity, and/or safety.
  • Maintain and trend quality metrics.
  • Perform lot history record review, releasing manufacturing lots and issuing certificates of conformance to customers.
  • Serve as a subject matter expert in quality assurance on cross-functional teams ensuring compliance to the compliance with applicable regulatory requirements, standards, and company policies.

Benefits

  • Employee and/or Employee + Child(ren) medical insurance costs you just $1/month!
  • Comprehensive Dental + Vision
  • 401k Retirement Plan that we match up to 3%
  • Basic Life AD&D Insurance
  • Employee Assistance Program
  • Paid time off — 18 days first year (pro-rated)
  • Paid holidays — 9 days
  • Annual Performance Bonus Potential
  • Employee Profit Sharing
  • Tuition Assistance
  • Shift differential: 2nd shift – + $1/hr, 3rd shift – + $3/hr
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