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:

This position assists in the establishment, implementation, and maintenance of programs crafted to assure control of processes and products toward established standards of quality. The position uses problem solving techniques to increase quality and efficiency within the Business Unit / Department. Also supports product leadership and risk management of new product development, product launches and sustaining activities.

Responsibilities:

• Develop, change, and supervise Quality inspections to ensure the greatest value in quality control for the customer and the plant during the manufacturing process while meeting regulatory requirements.
• Process monitoring and adjustment, process improvement, and product improvement including corrective action plans to address process/product issues.
• Documentation of activities along with the review and maintenance of operating procedures as well as department specific-procedures.
• Develop, implement, and improve Quality procedures applicable to the manufacturing process for assigned product lines.
• Coordinate efforts with other Departments to establish controls and process capabilities for assigned product lines.
• Actively support and provide input for process validation, process acceptance, internal and external audits and resulting corrective actions.
• Supervise the performance of assigned product lines regarding product quality, scrap, rejection rates and other applicable metrics.
• Review and develop changes in existing or proposed processes or requirements to achieve optimum performance and cost.
• Assume a leadership role in analyzing and resolving process/product issues.
• Develop, or improve test methods for inspection, including Test Method Validation.
• Monitor customer complaints and trends. Responding with specific corrective actions and customer interfacing as needed.
• Ensure that all company safety rules and regulations are followed and promoting general plant safety.
• Develop/update and implement procedures to stay in sync with corporate and industry standards.
• Day-to-day supervision and coordination of QA Technicians.
• Other duties and projects, as assigned.

Requirements:

• Bachelor's degree in engineering, and minimum of four (4) years' experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industry Required,
• Master's degree in engineering, and minimum of two (2) years' experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent regulated industry.
• Quality Engineering Certification (ASQ) or equivalent.
• Ability to apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.).
• Sophisticated statistical and risk assessment techniques.

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