JOB DESCRIPTION:
Opportunity: Quality Auditor
Join Abbotts Core Diagnostics Division where we empower smarter medical and economic decision-making to transform how people manage their health throughout life. Every day over 10 million tests are performed on Abbotts diagnostic instruments delivering critical lab results to millions worldwide.
We are currently seeking a Quality Auditor to support our Global Compliance and Auditing this role you will conduct internal supplier and affiliate audits to ensure compliance with regulatory standards company policies and proceduresdriving excellence and continuous improvement across our operations.
What Youll Do
- Conduct audits of suppliers affiliates and manufacturing sites to ensure compliance with government regulations international standards (e.g. ISO 13485 MDSAP) and company policies.
- Document audit findings in comprehensive reports for management review.
- Lead audit teams including technical experts and auditors-in-training.
- Maintain audit records and manage re-audit documentation.
- Mentor and guide junior auditors and volunteers.
- Contribute to the development of audit procedures and best practices.
- Stay current with regulatory changes through industry engagement.
- Adhere to company guidelines for travel health safety and environmental practices.
Required Qualifications
- Bachelors degree in a related science or engineering field or equivalent experience.
- Proven experience conducting and managing audits with expertise in ISO 13485 and MDSAP.
- Strong understanding of FDA CFR Part 820 and ISO 13485 regulations.
- Proficiency in quality management principles auditing techniques and statistical analysis.
- Ability to lead audit teams and communicate effectively with regulatory bodies and internal stakeholders.
- Skilled in Microsoft Office and comfortable interfacing with independent auditors.
- ISO Lead Auditor or ASQ Certified Quality Auditor (CQA) certification preferred.
What We Offer
As a global healthcare leader Abbott offers an exceptional benefits package including:
- Competitive salary
- Defined contribution pension scheme
- Private healthcare
- Life assurance
- Flexible benefits program
Build your future and live your best life with Abbott.
We are proud to be an Equal Opportunity Employer committed to fostering a diverse and inclusive workplace.
Apply now or connect with us:
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The base pay for this position is
N/A
In specific locations the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
CRLB Core Lab
LOCATION:
United Kingdom > Maidenhead : Remote
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes 50 % of the Time
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable