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.

Responsibilities:

• Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, procedures and guidelines, the duties and responsibilities for this position are:
• Develop and implement qualification plans: Design comprehensive test protocols and procedures to evaluate components against specified requirements and industry standards.
• Document and report findings: Accurately record test results, analyze data, and generate detailed reports summarizing findings and conclusions for management and stakeholders.
• Collaborate cross-functionally: Work closely with R&D, Manufacturing, and Quality teams to optimize component selection, address issues, and ensure compliance with medical device regulations throughout the product lifecycle.
• Support continuous improvement: Identify opportunities to enhance component qualification processes, methodologies, and test procedures to improve efficiency and effectiveness.
• Supplier evaluation: Assist in the evaluation and qualification of component suppliers, ensuring their manufacturing processes and quality controls meet established standards.
• Troubleshooting and root cause analysis: Investigate component failures or nonconformances, identify root causes, and implement effective corrective and preventive actions.
• Maintain documentation: Ensure all qualification documentation, including protocols, reports, and procedures, is accurate, up-to-date, and compliant with regulatory requirements.
• Experience with statistical techniques like Design of Experiments (DOE) and data analysis tools.
• Knowledge of specific component types or technologies relevant to the BWI product portfolio.
• Can supervise, coordinate and technically revise the work of a limited group of technicians
• Know & follow policies & procedures related to work activities performed in area of responsibility.
• Complete training in area of responsibility within allowed time-period and periodic retraining in areas.

Requirements:

• GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 13485 and regulatory affairs.
• Strong creative, analytical and problem-solving skills.
• Proficient at interpreting data and putting that data into a report.
• Experience in PLM Tool (Windchill)
• Process experience, ability to observe and understand manufacturing processes
• Excellent Interpersonal / communication skills, Organizational / planning skills preferred
• Personal computer skills, Windows: word processing, presentation, e-mail, web browsers & spreadsheet software
• Ability to work efficiently, meet timelines, and communicate status (generate trackers, send emails, etc.)
• Strong communication skills. Candidates must be highly proficient in reading, writing, and speaking English language.
• Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy is required.
• Employee must be able to effectively prioritize and manage multiple activities and responsibilities.
• Ability to understand and follow complex written procedures is required.
• Ability to function in a team environment and deliver on team objectives is required.
• Ability to make decisions and solve problems while exhibiting situational judgement.

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