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Manufacturing Quality Assurance Specialist

2 months ago

Reedsville, Pennsylvania, United States Philips Full time
Job Title

Manufacturing Quality Assurance Specialist

Job Description

As a key member of the Philips team, the Manufacturing Quality Assurance Specialist will play a critical role in ensuring the quality of our manufacturing processes. This position will oversee the Quality Assurance in the processes related to the manufacturing of materials, components, sub-assemblies, and completed products and their supply chain, including compliance to regulatory requirements and/or procedures for regulated products/businesses.

The ideal candidate will have a strong background in quality assurance and a proven track record of ensuring compliance with regulatory requirements. They will be responsible for the introduction/validation of new/changed manufacturing processes and their associated quality systems, trend analysis and monitoring of manufacturing processes and their environment, remediation to non-conformances, and the development and improvement of quality systems.

Your Key Responsibilities:

  • Ensure that appropriate quality plans are made and a suitable quality system is in place, for both NPIs as well as for ongoing manufacturing that include all stages of the manufacture of the product/system and supports Quality System design
  • Validate risk analyses and risk mitigation plans and activities, control plans, and Quality Systems
  • Oversee processes: trend analysis, assess impact and follow-up (e.g., in QS updates, control plans, competency upgrades, etc.)
  • Review calibration plans and records, environmental controls, and training plans and records
  • Organize IQA audits, and execute internal audits for regulated products to assess the effectiveness of the QMS linked to production controls
  • Approve which processes need validation/re-validation

Requirements:

  • 5+ years of engineering experience in the related field or a combination of equivalent education and relevant experience
  • Proficiency in the use of various measuring tools and troubleshooting equipment
  • Bachelor's Degree in Mechanical Engineering, Biomedical Engineering, Process Engineering or related technical discipline, preferred
  • Solid experience in Risk Management for medical devices ISO 14971 and regulated industry experience
  • Knowledge of statistical analysis (Minitab)
  • Excellent communication and people skills to engage with diverse stakeholders, including leadership team, project teams, vendors, and regulatory agencies

About Philips

We are a leading health technology company dedicated to improving people's lives through innovative healthcare solutions. Our mission is to make a meaningful difference in the lives of our customers and patients. We are committed to creating a workplace that is inclusive, diverse, and rewarding for our employees.

What We Offer:

  • A dynamic and collaborative work environment
  • Opportunities for professional growth and development
  • A comprehensive benefits package
  • A commitment to diversity, equity, and inclusion

Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.