Software quality assurance engineer Jobs in Florissant mo

About Curium

Curium is the world's largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.

With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name 'Curium' honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline 'Life Forward' represents our commitment to securing a brighter future for all those we serve : An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.

Summary of Position

The Senior Quality Assurance Engineer is the primary Quality Assurance contact to ensure quality compliance for manufactured products. The Senior Quality Assurance Engineer investigates and approves exceptions, out of specifications with root cause analysis tools to ensure appropriate corrective actions are identified to reduce and prevent recurrence. The Senior Quality Assurance Engineer supports or initiates continuous quality improvement activities.

Schedule : Monday - Friday 8am 5pm

Essential Functions

• Review and approve Change Control, and Quality documents involving product or process changes.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC / S, ISO, USP, NRC, cGMP, etc.).
• Review and approve validations (equipment, cleaning and / or process) for assigned area Prepares and participates in regulatory agency (i.e. FDA, HC, TGA ,etc.) audits as well as internal audits.
• QA contact for risk management activities, including FMEA's (Failure Modes and Effects Analysis).
• Investigate or serve as QA approver for customer complaints, exceptions / out of specifications ensuring root causes and corrective actions are appropriately identified to reduce / prevent recurrence, within required timeframes and documented in the sites EQMS (Electronic Quality Management System).
• Assemble, analyze and report QA data to ensure regulatory compliance, identify trends and to identify areas of improvement.
• Develop, review and / or revise SOP (standard Operating Procedures), BR's (Batch Records), STM (Standard Test Methods), Specifications, FMEA's.
• Ability to adapt quickly in a fast-paced dynamic environment.
• Ability to communicate with and positively influence broad and diverse populations within and outside the organization.

Requirements

Working Conditions :

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Equal Opportunity Employer

Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

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