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Abbott · 10 hours ago

Quality Engineer

San Diego, CA

Full-time

Onsite

Entry, Mid Level

$80K/yr - $139K/yr

2+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Quality Engineer position focuses on developing and maintaining quality engineering methodologies and providing support within new product development and manufacturing.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Develop and maintain quality engineering methodologies and provide quality engineering support within new product development, manufacturing, or system/services support

Identify, review, 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

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

Appropriately document experiment plans and results, including protocol writing and reports

Draft and review the CTQ parameters and specifications

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)

Qualification

Quality tools/methodologiesStatistical/data analysisSix SigmaLean ManufacturingMedical device experienceChange managementNon-Conformance/CAPAProject managementCommunication skillsInterpersonal skillsOrganizational skillsAttention to detail

Required

Bachelor's degree in Science, Engineering or a closely related discipline

More than 2 years' Engineering experience and demonstrated use of Quality tools/methodologies

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 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

Preferred

Prior medical device experience preferred

Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing). ASQ CQE or other certifications preferred

Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment

Previous experience reviewing validation and transfer activities related to documentation control processes

Americal Society of Quality (ASQ) and Certified Quality Engineer (CQE) or other certifications preferred

Previous experience with Change management, and Non-Conformance/CAPA

Benefits

Career development with an international company where you can grow the career you dream of.

Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

An excellent retirement savings plan with a high employer contribution

Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.