Senior Quality Assurance Specialist

3 weeks ago


Mansfield, Ohio, United States Volt Workforce Solution Full time
Job Overview

Volt Workforce Solutions is seeking a highly skilled Senior Quality Assurance Specialist to join our team in Mansfield, MA. This role will play a critical part in ensuring the highest quality products and processes within our manufacturing operations.

Compensation

The estimated annual salary for this position is $93,600-$124,800, based on a range of $45-$60 per hour.

Responsibilities
  • Develop and implement effective risk management strategies to prevent unanticipated failures and improve process capability.
  • Support and supervise processes in base business, as well as lead and mentor other engineers and technicians.
  • Work on non-conforming reports, including initiation, analysis, investigation, review, and closure.
  • Collaborate with third-party suppliers to resolve issues related to non-conformities.
  • Conduct internal and supplier audits of facilities in accordance with ISO-1385 and/or 21CFR820 standards.
  • Design, interpret, and implement appropriate process monitoring and control methods aligned with process/product risk levels.
  • Analyze data and execute various statistical analyses to support process improvements and day-to-day activities.
  • Investigate, document, review, and approve nonconformances, CAPAs, and customer complaints, escalating quality issues as necessary.
Requirements
  • Bachelor's degree or equivalent with 8+ years of experience, master's degree with 5+ years of experience, or doctoral degree with 3+ years of experience.
  • Relevant experience working in manufacturing/operations is required.
  • In-depth knowledge of product/process risk management (FDA and ISO standards) is essential.
  • Proven track record of implementing effective risk mitigation strategies.
  • Certified Internal Auditor to ISO-13485 is preferred.
  • Advanced knowledge and experience in areas related to the duties and responsibilities associated with the position.
Benefits

Volt Workforce Solutions offers a comprehensive benefits package, which includes health, dental, vision, term life, short-term disability, AD&D, 401(k), sick time, and other paid leaves (as required by law). We are an equal opportunity employer and prohibit any form of unlawful discrimination and harassment.



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