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Quality Assurance Manager

1 month ago

Shelton, Connecticut, United States PerkinElmer Full time

Job Title: Quality Assurance Manager

Job Summary:

We are seeking a highly skilled Quality Assurance Manager to join our team at PerkinElmer. The successful candidate will be responsible for maintaining the Quality Management System (QMS) for the OneSource Enterprise Global Business Unit.

Key Responsibilities:

  • Ensure effectiveness and compliance to ISO 9001:2015 QMS as the Global OneSource Enterprise Quality Management Representative.
  • Partner with leadership to construct a Quality program to ensure the organization delivers an exceptional customer experience.
  • Ensure consistent lab service quality across global accounts to drive overall customer satisfaction.
  • Liaison between customer accounts and OneSource team for service quality feedback.
  • Chair quality management reviews and manage internal & external audits.
  • Provide advice and support to the service account owners on quality issues/initiatives.
  • Evaluate and support quality agreement evaluations, supplier approval review, equipment calibration records, CAPAs, complaint investigations, document change control, and LMS training compliance.

Requirements:

  • Bachelor's degree in a relevant field
  • 5+ years of experience managing Quality Management Systems within the medical device or pharmaceutical industry or under an ISO 13485:2016 or ISO 9001:2015 QMS
  • 3+ years of management experience
  • Knowledge of regulatory requirements and standards relevant to manufacturing such as (ISO45001/OHSAS18001 and ISO14001)
  • Strong customer focus with complaint investigation, significant event reporting, and CAPA skills
  • Must communicate fluently in English

Preferred Characteristics:

  • Internal Auditor certification
  • Strong data analysis skills and proficiency in electronic data management systems
  • Good understanding of quality management systems and tools such as PPAP, FMEA, and SPC
  • Ability to work independently and collaborate effectively with cross-functional teams
  • Proficiency in SAP, ServiceMax, SharePoint, Microsoft Excel, Word, and PowerPoint