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Senior Quality Engineer
Job Opportunity at
Posted on Aug 22
Los Angeles Area, CA
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The Sr. Quality Engineer will support compliance activities associated with drug/device combination products.
Possess good understanding of drug/device combination product regulations including but not limited to specific areas such as drug product manufacturing, design control, stability, reserve samples, sterile processing, quality control, process validations and monitoring. Lead/drive the implementation of assurances, process controls, and CAPA systems designed to meet or exceed such regulations
Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
Lead, coach, and mentor non-exempt and entry level exempt personnel
Assist in the development and execution of streamlined quality systems which effectively identify and resolve quality issues
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Challenge the design and experiments for process optimization and/or improvement
Appropriately document experiment plans and results, including protocol writing and reports
Lead process control and monitoring of CTQ parameters and specifications
Support implementation of various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing)
Lead and/or support the investigation, resolution and prevention of product and process nonconformances, out of specification issues
Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
Lead in the completion and maintenance of risk analysis
Work with process engineering and analytical chemistry groups in the completion of process validations, and product stabiltiy studies
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Performs other related duties and responsibilities, on occasion, as assigned.
BS degree in Engineering (Chemical, pharmaceutical or equivalent) or Technical Field or equivalent experience; advanced degree preferred
6+ years experience, 2+ of which should consist of drug or combination product experience
Demonstrated supervisory experience preferred
Engineering experience and demonstrated use of Quality tools/methodologies
Strong knowledge of combination product/drug FDA regulations and GMP, ISO 13485, and ISO 14971 requirements
Solid communication and interpersonal skills
Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
Advanced computer skills, including statistical/data analysis and report writing skills
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multitasks, prioritizes and meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Ability to travel approximately 10%.
Ability to maintain regular and predictable attendance.
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