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Abbott · 8 hours ago

Quality Assurance Engineer

Pomona, CA

Full-time

Onsite

Mid, Senior Level

$80K/yr - $139K/yr

5+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Quality Assurance Engineer position plays a critical part in ensuring product and process quality, compliance, and continuous improvement across operations.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Lead quality engineering activities related to :

Product and process changes

Product/process quality issues

Compliance concerns

Partner with operations to drive process improvement and continuous improvement initiatives

Conduct process audits within operational areas to ensure adherence to quality standards

Support the development of new products, including participation in design control activities

Actively partner with operations to perform process audits to identify and implement improvement initiatives as required

Identify, review, and implement effective process control systems to support the development, qualification, and/or on-going manufacturing of products to meet or exceed internal and external requirements

Support the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations

Perform Risk Assessments, as required, across functions, including FMEA, change management, and issue investigation / resolution

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

Assist in the review, 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

Perform root cause analysis of product quality issues. Apply appropriate tools (e.g. statistics, fault tree analysis, etc.). Work with peers to develop corrective actions

Perform failure mode analysis on new or existing products. Ensure all reasonable failure modes are identified. Working with peers, develop mitigations for failure modes, and verify the effectiveness of these mitigations

Work on problems of limited scope

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

Lead process control and monitoring of CTQ parameters and specifications as required

Appropriately document experiment plans and results, including protocol and report writing/reviews

Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)

Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained

Coordinates for both new products/processes and changes to existing products/processes develop verification and validation plans that assess if requirements are met

Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices

Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities

Carries out duties in compliance with established business policies

Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies

Perform other duties and projects as assigned

Qualification

Quality AssuranceRoot Cause AnalysisProcess ValidationStatistical ToolsFDA RegulationsLean ManufacturingProject ManagementAnalytical SkillsInterpersonal SkillsProblem SolvingAttention to Detail

Required

BS/BA degree in Engineering or Technical Field

Five years of experience; preferably engineering experience and demonstrated use of Quality Tools-methodologies

Solid communication and interpersonal skills

Strong computer skills including MS office

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

Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor

Must be detail-orientated, self-motivated and available for flexible scheduling