Senior Quality Engineer

1 month ago

North Haven, United States Planet Pharma Full time

The Senior Quality Engineer is responsible to represent the quality engineering function to develop and execute the strategy to organize, direct, and report on all supplier quality-related activities for design and manufactured items made for the AST stapling business platform.

Primary duties are focused on matter pertaining to supplier selection, qualification, manufacturing, and review of technical quality documentation that includes Risk Management Documentation.

  • Lead PPAP qualifications with the CMs
  • Collaborate with CMs to develop robust SCAPAs
  • Support the Quality team (member of) to develop and improve an effective Supplier Quality process that supports finished goods product quality globally.
  • Work with new and existing CMs/Suppliers to develop, implement, and maintain technical quality assurance systems and activities, including MSAs, SPC, Quality Plans, Control Plans, and FMEAs
  • Collaborate on New Product Development (NPD) teams to evaluate and understand future CMs and their associated quality and development plans
  • Build and own the strategy for managing the CMs/Suppliers for the business
  • Communicate with the business Quality lead on CM initiatives, updates, and issues
  • Partner with Supplier Quality Managers to build a strategy for managing the CMs in all regions
  • Ensure CM compliance with business Quality Systems and all relevant internal procedures and policies
  • Facilitate customer complaints for CM products and ensure adequate investigation and corrective actions are taken by CMs
  • Manage Supplier Corrective Action Request program to ensure consistency in handling corrective actions by CMs
  • Develop, communicate, and manage a strategy/plan for addressing finished goods CMs/Suppliers capability deficiencies, etc.
  • Ensure proper approval and documentation practices are followed for any process, material or tooling change (SCR – Supplier Change Request) at CMs
  • Define and manage the process for growing effective "partnerships" with preferred CMs (to drive optimal performance) founded on common interest and which demonstrate trust, loyalty and financial success
  • Lead by Example: Setting continuous-improvement driven mentality and solid quality culture for the organization
  • Maintain compliance to set Key Performance Indicators for the business
  • Maintain the highest level of compliance and operational standards set by the business
  • Manage and report on CMs/Suppliers audit program in line with ISO and/or FDA 21 CFR part 820 regulations
  • Translate engineering, manufacturing, and quality requirements for CM products
  • Perform deviation investigations into quality issues arising from CM activities
  • Manage qualifications of changes and co-ordinates associated change control activities
  • Evaluate CMs using the appropriate CM performance management processes and develop reports on CM quality performance for company management, recommend and implement the continuous improvement of CM quality systems
  • Responsible for ensuring that effective up-to-date CM Quality Assurance documentation, procedures, and specifications are maintained
  • Participate in annual supplier forums and business reviews

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