[Remote] Quality Auditor at Abbott

United Kingdom

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, DiagnosticsIndustries

Requirements

Candidates must possess a Bachelor's degree in a related science or engineering field, or equivalent experience, along with proven experience in conducting and managing audits, specifically in ISO 13485 and MDSAP. A strong understanding of FDA CFR Part 820 and ISO 13485 regulations, proficiency in quality management principles, auditing techniques, and statistical analysis are required. The role also necessitates the ability to lead audit teams, communicate effectively, and proficiency in Microsoft Office. ISO Lead Auditor or ASQ Certified Quality Auditor (CQA) certification is preferred.

Responsibilities

The Quality Auditor will conduct internal, supplier, and affiliate audits to ensure compliance with regulatory standards, company policies, and procedures. Responsibilities include documenting audit findings in comprehensive reports, leading audit teams, maintaining audit records, mentoring junior auditors, and contributing to the development of audit procedures. The role also involves staying current with regulatory changes and adhering to company travel, health, safety, and environmental practices.

Skills

ISO 13485

MDSAP

FDA CFR Part 820

Quality Management Systems

Auditing Techniques

Statistical Analysis

Microsoft Office

Lead Audit Teams

Supplier Audits

Affiliate Audits

Manufacturing Site Audits

Regulatory Compliance

ISO Lead Auditor Certification

ASQ Certified Quality Auditor (CQA)

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.

Land your dream remote job 3x faster with AI

Try Jobo Free