Senior Quality Assurance Specialist (CAPA) at Abbott

Zurich, Zurich, Switzerland

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

A Bachelor’s or Master’s degree in Science, Engineering, or a related technical field
At least 5 years of experience in the medical device industry, ideally in a quality-focused role
Strong skills in non-conformance handling, root cause analysis, and CAPA implementation
Solid understanding of international medical device regulations: ISO 13485:2016, 21 CFR Part 820, EU MDD/MDR, ISO 14971 (Risk Management)
Familiarity with ISO 11135:2018 and/or IEC 60601-1 is a plus
Excellent communication skills in English
Strong organizational and time management abilities
A proactive, ethical mindset and the ability to work both independently and collaboratively
Confidence using technical software and digital tools

Responsibilities

Guide and mentor colleagues through CAPA methodology and execution
Manage CAPA lifecycle from initiation to closure, ensuring timely and effective outcomes
Review and approve CAPAs, supporting thorough investigations and root cause analysis
Oversee implementation and verification of corrective and preventive actions
Support the development and maintenance of quality procedures aligned with global standards
Monitor compliance across departments and promote best practices
Function as contact point for compliance topics to empower teams with quality knowledge
Collaborate with subject matter experts on microbiological controls and EtO sterilization
Contribute to environmental monitoring, sterility assurance, and validation activities
Help ensure compliance with ISO 11135 and related regulatory frameworks

Skills

CAPA

Root Cause Analysis

Quality Assurance

Corrective Actions

Preventive Actions

Quality Procedures

Compliance Monitoring

Regulatory Affairs

Cross-functional Collaboration

Mentoring

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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