Apply on Employer Site

Abbott · 1 month ago

Sr. CAPA Quality Engineer

Alameda, CA

Full-time

Onsite

Mid, Senior Level

$87K/yr - $173K/yr

6+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Sr. CAPA Quality Engineer will lead and mentor a team of Quality Engineers, ensuring oversight of the CAPA system and driving continuous process improvements.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Lead, mentor and motivate a team of Quality Engineers

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

Accountable for leadership and oversight of the CAPA system, and associated deliverables

Provide guidance, insight and training to the team and the wider business around CAPA process, quality standards, and regulatory requirements

Lead and/or contribute to continuous improvement initiatives and projects

Provide subject matter expertise during audits and inspections

Represent CAPA QA in cross functional meetings (site and division)

High proficiency leading meetings and communications for QA system information, concerns, and updates

Lead, develop, and mentor others with QA data analysis, trending, and reporting. High proficiency with reporting and publishing weekly, monthly, and quarterly metrics

Adept at staying current with organizational and industry information and routinely mentors/leads other members of the organization on quality assurance practices

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

Qualification

CAPA experienceQuality AssuranceFDA regulationsStatistical analysisProject managementCommunication skillsInterpersonal skillsOrganizational skillsAttention to detail

Required

B.S. in Engineering, Technical Field, Life Science or closely related discipline. Equivalent combination of education and work experience will be accepted

Minimum 6 years in Quality or related field experience

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

Preferred

Prior medical device experience

Masters degree

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

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.