Sr Quality Engineer

Job Description

Senior Quality Engineer role at Katalyst CRO. The Senior Quality Engineer represents 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 for the AST stapling business platform. Primary duties focus on supplier selection, qualification, manufacturing, and review of technical quality documentation, including Risk Management Documentation.

• Lead PPAP qualifications with the contract manufacturers (CMs).
• Collaborate with CMs to develop robust SCAPAs.
• Support the Quality team 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) at CMs.
• Define and manage the process for growing effective partnerships with preferred CMs to drive optimal performance based on trust, loyalty, and financial success.
• Lead by example with a continuous-improvement driven mentality and a strong quality culture.
• Maintain compliance with set Key Performance Indicators for the business and high operation standards.
• Manage and report on CMs/Suppliers audit programs 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 coordinate associated change control activities.
• Evaluate CMs using appropriate performance management processes and develop reports on CM quality performance; recommend and implement continuous improvement of CM quality systems.
• Ensure that up-to-date CM Quality Assurance documentation, procedures, and specifications are maintained.
• Participate in annual supplier forums and business reviews.

• 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.
• Experience with PPAP, DFMEA, risk management documentation, and supplier changes (PPAP) expertise.
• Experience 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.

• Associate

• Contract

• Quality Assurance
• Industries
• Pharmaceutical Manufacturing

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