Quality Assurance Senior Associate

4 days ago

Pulong Santa Cruz, Calabarzon, Philippines Ivoclar Vivadent Services & Support, Inc. Full time $60,000 - $80,000 per year

As the deputy for the Nonconformity Management process owner, you will handle and document nonconformities in compliance with regulations. You will serve as a subject matter expert and point of contact for the nonconformity documentation system, supporting product and process optimization. Additionally, you will monitor and escalate process metrics to ensure timely closure and compliance with documentation requirements.

Key Responsibilities:

  • Conduct root cause and risk assessments
  • Decide on product usage decision and define corrective actions
  • Ensure deviations comply with standards (e.g., FDA 21 CFR 820, ISO 13485, MDR (EU) 2017/745, MASAP)
  • Coordinate with various departments (Purchasing, Packaging, R&D, Regulatory Affairs, etc.)
  • Document nonconformities and related actions
  • Prepare and analyze statistics on nonconformities
  • Follow up on actions in IT systems (e.g. SAP, LABS/Q, OTCS)
  • Support validations, changes, and IT system tasks
  • Train on the Nonconformity process and related software
  • Continuously improve the Nonconformity process
  • Participate in projects
  • Implement and comply with safety and regulatory requirements
  • Act as a role model in alignment with Ivoclar Group values

What You'll Bring:

  • Graduate of Bachelor's Degree in any related field
  • Training in the dental industry or equivalent education with further training in Quality Assurance/Quality Management
  • Minimum of 2-3 years of experience in Quality Assurance/Quality Management
  • Expertise in the English & German language (CEFR C1)
  • Knowledge in the medical technology sector
  • Excellent verbal and written skills in German and English
  • Proficient in MS Office and SAP
  • Knowledge in ISO 13485, otherwise, must have background in pharmacy/automotive industry
  • Cost-conscious, strong communication skills, confident in negotiations, initiative-driven, team player, assertive

What We Provide:

  • TRAINING: You will work with various members of our team locally and onshore to ensure you are set up for success.
  • SUPPORT: A close-knit coaching and mentoring system to help you ease into the company and into your role with confidence.
  • COMP & BEN: Ivoclar believes in compensating employees fairly for their skills and experience and has designed the total rewards package for long-term relationships.
  • TOOLS: Everything you need to help you do your work will be provided.
  • WORKING ENVIRONMENT: Ivoclar prides itself on being a family-owned company with strong values so everyone we bring in becomes part of that global family.

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