Senior Global Director of Quality Assurance

4 weeks ago

Camarillo, California, United States Hygiena LLC Full time
Job Overview

Hygiena LLC is seeking a highly skilled Senior Global Director of Quality Assurance to lead our quality assurance efforts. This role will be responsible for ensuring the highest quality products and services are delivered to our customers.

Key Responsibilities:

  • Lead and manage the Quality Assurance team to ensure compliance with regulatory requirements and company standards.
  • Develop and implement quality systems to ensure FDA and ISO compliance.
  • Collaborate with facility quality leaders to identify best practices and implement processes aimed at improving quality results.
  • Optimize quality systems to effectively identify, measure, and reduce cost of quality activities.
  • Responsible for all aspects of environmental programs, employee health and safety, and developing, planning, establishing, implementing, and maintaining all health, safety, and environmental programs to assure regulatory compliance.
  • Oversee and maintain effective audit programs, including internal and supplier compliance audits, as well as external audits (FDA, ISO, environmental, etc.).
  • Maintain an effective Quality Management System (QMS); facilitate Management Review meetings and related data analyses.

Requirements:

  • Bachelor's Degree in Engineering (Mechanical or Biomedical Engineering preferred) or related field, or equivalent education and work experience, required.
  • Minimum of 7-10 years' experience in federally regulated industry to include QA, compliance, and/or Regulatory Affairs.
  • Minimum of 5 years' experience in a managerial role in a multi-business unit setting (global preferred).
  • ASQ Certification (CQE, CRE, CQA, CQM) preferred.
  • Strong working knowledge of QSR, ISO 13485, MDR, and ISO14971 (Risk Management) requirements.
  • Strong knowledge of Microsoft Office (Outlook, Word, Excel, Visio, PowerPoint).
  • Experience with conducting quality audits (internal and supplier, as well as managing and hosting external audits (e.g. FDA, ISO).
  • Experience in continuous improvement methods such as Six Sigma, Kaizen, or Lean Manufacturing; Lean/Six Sigma Black Belt certification preferred.

Benefits:

  • 15 days of PTO & 9 paid company holidays
  • Medical with HSA employer contribution, Dental, Vision available 1st of the month after start date
  • Company paid Life Insurance, Short* and Long-Term Disability and an Employee Assistance Program
  • 401(k) with Safe Harbor and Profit-Sharing employer contributions
  • Tuition Reimbursement program
  • Charitable Contribution matching
  • Employee Referral bonus opportunities

Hygiena LLC is an equal opportunity employer and values diversity. All employment is decided on the basis of qualifications, merit, and business need. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Hygiena LLC participates in E-Verify

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