Katalyst Healthcares and Life Sciences
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.
- 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.
- 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.