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Sr Quality Engineer
Sr Quality EngineerKatalyst Healthcares and Life Sciences • North Haven, CT, United States
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Sr Quality Engineer

Sr Quality Engineer

Katalyst Healthcares and Life Sciences • North Haven, CT, United States
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Job Description :

  • 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.

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.

    • Requirements :

  • Bachelor's Degree in an Engineering / Scientific / Electronic or technical field.
  • Minimum 5 years' experience in a Supplier Quality, Quality Engineering or Reliability Engineering function.
  • ctivities PPAP.
  • Design Failure Mode and Effect Analysis (DFMEA).
  • Risk management documents.
  • Supplier changes (PPAP) expertise.
  • Risk management documents.
  • 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.
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