Job Description

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

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.
• Activities 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.

Additional Information

All your information will be kept confidential according to EEO guidelines.

Job Tags

Similar Jobs