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Company

Original Job Post

Abbott · 2 days ago

Senior Engineer Development Quality

Los Angeles, CA

Full-time

Onsite

Senior Level

$84K/yr - $167K/yr

5+ years exp

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Responsibilities

Lead on-time completion of Design Control Deliverables

Work with R&D and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes, including active cross-functional root-cause analysis investigation & resolution activities

Create and execute or direct validation protocols traceable to system/software requirements. Execute and support on-time completion of Quality Engineering deliverables: test plans (manual and automated), test scripts (manual and automated), test reports

Provide guidance and training to the site engineers for Software Validation, Data Integrity, Software Requirement Specification (SRS), Cybersecurity and also other support software systems.

Lead CAPA investigations through effective root cause analysis and corrective action implementations

Lead Risk Management activities from product Concept through Commercialization including cybersecurity risks

Support manufacturing process development & qualification for new product commercialization and product changes

Support/lead and ensure internal & external audit responses

Support/lead and ensure on time product re-certifications

Support and ensure the establishment of objective, measurable, discrete, and verifiable customer, product and nonproduct software requirements

Design and implement various product and process improvement methodologies (ie Six Sigma and Lean Manufacturing).

Complete Document Change Request Reviews in a timely and objective manner

Develop and lead other team members.

Perform other duties and responsibilities as assigned by management.

Support/lead 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.

Qualification

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Quality engineeringFDA regulationsGMPISO 13485Statistical analysisReport writingMedical deviceASQ CQE certificationDesign for Six SigmaCritical to QualityEnterprise experienceDeadline managementCommunicationInterpersonalProject managementLeadershipProblem-solvingTeamworkVerbal communicationWritten communicationMultitaskingPrioritizationOrganizational skillsAttention to detailMasters Degree

Required

Bachelors Degree Engineering or Technical Field Or an equivalent combination of education and work experience

Minimum 5 years

Previous Quality engineering experience and demonstrated use of Quality tools/methodologies. Detailed knowledge of FDA, GMP, and ISO 13485

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.

Prior medical device experience preferred. ASQ CQE certification preferred. Design for Six Sigma and Critical to Quality training and experience 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. 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%, including internationally(if required)

Preferred

Masters Degree Preferred

Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.