Sr. CAPA Quality Engineer at Abbott

Alameda, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, DiagnosticsIndustries

Requirements

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
High proficiency leading meetings and communications for QA system information, concerns, and updates
High proficiency with reporting and publishing weekly, monthly, and quarterly metrics
Adept at staying current with organizational and industry information
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments

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)
Lead, develop, and mentor others with QA data analysis, trending, and reporting
Drive CAPA projects through its entire life cycle
Mentor lower-level engineers
Strategize continuous process improvements that aid in improving the CAPA program

Skills

Key technologies and capabilities for this role

CAPAQuality EngineeringMedical DevicesGlucose MonitoringBio-wearable TechnologyDiabetes CareHealthcare Regulations

Questions & Answers

Common questions about this position

What benefits does Abbott offer?

Abbott provides free medical coverage in the Health Investment Plan (HIP) PPO medical plan, an excellent retirement savings plan with high employer contribution, tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit for earning a bachelor’s degree.

Is this position remote or onsite?

The position is based out of Abbott Diabetes Care Division in Alameda, CA, and requires being onsite Monday through Friday.

What are the key responsibilities and skills for this Sr. CAPA Quality Engineer role?

The role involves leading and mentoring a team of Quality Engineers, overseeing the CAPA system, communicating effectively with all levels, providing guidance on CAPA processes and regulatory requirements, and leading continuous improvement initiatives.

What is the company culture like at Abbott?

Abbott emphasizes work that matters, career growth, caring for employees and families, being your true self, and living a full life. It is recognized as a great place to work worldwide, one of the most admired companies by Fortune, and excels in diversity, working mothers, female executives, and scientists.

What makes a strong candidate for this position?

A strong candidate should have senior-level experience in CAPA systems, the ability to lead and mentor Quality Engineers, strong communication skills for all levels, and expertise in quality standards, regulatory requirements, and continuous improvement.

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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