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Abbott · 5 hours ago

Quality Engineer II

Los Angeles, CA

Full-time

Onsite

Entry, Mid Level

$82K/yr - $141K/yr

2+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. They are seeking an experienced Quality Engineer II for their Sylmar, CA Operations Quality Engineering team, responsible for developing quality engineering methodologies and supporting new product development and manufacturing processes.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

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 in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements

Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues

Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues

Design and conduct 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

Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)

Lead the investigation, resolution and prevention of product and process non-conformances

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 design engineering in the completion of product verification and validation

Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities

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

Qualification

Quality EngineeringFDA RegulationsSix SigmaLean ManufacturingISO 13485ISO 14971Statistical AnalysisProject ManagementCommunication SkillsInterpersonal SkillsAttention to Detail

Required

BS degree in Engineering in Engineering or Technical Field or equivalent experience

Minimum 2 years

2-5 years Engineering experience and demonstrated use of Quality tools/methodologies

Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971

Solid communication and interpersonal skills

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