QMS Manager

PhilipsReedsville, PA
$120,000 - $186,000Hybrid

About The Position

In this role you Are responsible for overseeing the strategic management of the QMS department, aligning it with organizational goals and industry best practices.

Requirements

  • Bachelor's / Master's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent.
  • 5+ years of experience with Bachelor's in areas such as Quality Management Systems, Quality Audits or equivalent in highly regulated environments/industries such as Medical Device, Pharma, Automotive.
  • 5+ years of experience in leading teams with direct and indirect reports in complex matrix organizations and delivering on organizational objectives.
  • Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.

Responsibilities

  • Analyzes QMS performance data to identify trends, systemic issues, and improvement opportunities, and lead cross-functional teams in developing and implementing effective solutions to enhance quality and compliance.
  • Serves as a senior quality advisor and key point of contact for regulatory bodies, ensuring that QMS processes and practices are fully compliant, and effectively managing external audits, inspections, and follow-up actions.
  • Leads and manages complex, high-impact problem-solving initiatives using advanced quality tools and methodologies such as Six Sigma or Lean, ensuring effective resolution of critical quality issues and sustainable improvements.
  • Manages talent across the team, while driving employee selection, performance management, compensation management, career development, and ensuring effective operational management.
  • Oversees the management and resolution of non-conformance reports (NCRs), ensuring systematic tracking, thorough investigation, effective resolution, and implementation of preventive measures.
  • Coordinates risk assessments and risk management activities, identifying significant risks to product quality and QMS integrity, and developing and implementing robust mitigation strategies.

Benefits

  • generous PTO
  • 401k (up to 7% match)
  • HSA (with company contribution)
  • stock purchase plan
  • education reimbursement
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