Senior Quality Engineer

• 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:

• The Senior Engineer, External Manufacturing and Supplier Quality provides strategic and tactical support to External Manufacturing by executing quality activities such as base business support and nonconformance root cause investigation to maintain and improve customer satisfaction, eliminate errors and improve efficiency.
• The individual is responsible to build business partnerships with suppliers and internal stakeholders / technical experts (i.e. Procurement, Operations, R&D, Supply Chain, NPI) to eliminate supply chain risks, while implementing continuous and innovative improvements with demonstrated and measurable results.

Responsibilities:

• Provide sound, risk-based QA direction and independent and timely decision-making on a wide range of quality and compliance issues. Includes working with suppliers and internal resources to perform root cause analysis/failure investigations, identifying and approving of supplier corrective actions, and monitoring suppliers' implementation / effectiveness.
• Provides oversight and escalation for product related issues. Ensure compliant execution of Quality Management Systems including but not limited to EM: selection, change control, qualification, approved supplier list, NC/CAPA, Quality agreements and performance monitoring.
• Provide leadership across activities associated with supplier risk identification & management, including planning and execution of supplier risk & control plan assessments and the ownership and creation of Quality Agreements.
• Exercise strong communication and interpersonal skills, with the ability to work independently and in a team environment, to effectively support supplier relationship Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements under limited supervision Adaptable and flexible for other duties that may be assigned as needed

Requirements:

• Competencies.
• EIS Medical Device & Regulations.
• 4-6 Years of Experience.

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