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Abbott · 1 week ago

CAPA Engineer II

Alameda, 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. The CAPA Engineer II will facilitate and execute the CAPA process, ensuring compliance and quality in the development of new digital products for diabetes management.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Communicate confidently and effectively with all levels of management, peers and key stakeholders, including timely escalation of quality issues

Participate in, or lead, the completion of CAPA projects, assuring compliance, quality and timeliness of records

Collaborate with cross-functional teams using various methodologies (e.g. Six Sigma root cause analysis/problem solving skills)

Independently investigate, gathers data, and perform preliminary analysis

Process requests, ensuring owners are assigned, and timely responses and approvals are provided in alignment with quality goals

Lead meetings and communications for CAPA updates, information, and concerns

Responsible for assisting with metrics and reporting on regular basis in accordance with established procedures

Support team in the delivery and oversight of CAPA training program

Assist in the initiation, processing and completion of CAPA records in the electronic system

Execute and provide on-time completion of Quality Assurance engineering deliverables

Provide support and subject matter expertise during audits and inspections

Lead and/or contribute to continuous improvement initiatives and projects

Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments

Qualification

CAPA processFDA Quality System RegulationsISO 13485 2016Statistical analysisProject managementMultitaskingFollow-up skillsCommunication skillsInterpersonal skillsLeadership skillsAttention to detailTeamworkOrganizational skills

Required

A.S./B.S. in the engineering, healthcare, or science fields. Equivalent combination of education and work experience will be accepted

Minimum 2 year significant engineering and/or technical operational experience plus demonstrated competence

Previous CAPA and/or quality assurance/engineering experience and demonstrated use of quality tools/methodologies

Detailed knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485 : 2016

Solid communication and interpersonal skills

Demonstrated and impactful project management and leadership skills, including the 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 20%, including internationally

Ability to maintain regular and predictable attendance