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Senior Quality Engineer

3 months ago

North Haven, United States Planet Pharma Full time

608842


Our client, a leading Medical Device company in North Haven, CT, is looking for a Sr. Quality Engineer to be responsible for developing and executing the strategy to organize, direct, and report on all supplier quality-related activities for design and manufactured items made for their AST stapling business platform.


Required Skills:

  • Bachelor's degree required
  • Minimum 5 years experience in a Supplier Quality, Quality Engineering or Reliability Engineering function
  • Supplier changes (PPAP) expertise
  • Risk management document experience
  • Experience with working 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


Responsibilities:

  • 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



***Compensation within this range will be commensurate with level of experience***