Sr. Manager, Quality Assurance

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. Youll also have access to :

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 bachelors degree.

A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.

A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Atlanta,GA location in the Heart Failure Division. In Abbotts Heart Failure (HF) business, were developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.

As a Senior Quality Manager, the individual will play a crucial role within Abbotts Heart Failure organization with primary focus to maintain overall Quality Management System compliance to internal policies, applicable standards and external regulatory requirements.

What Youll Work On

• The incumbent defines and develops strategy for external and internal audits (Regulatory Agencies, Corporate, Notified Bodies, Certifications etc) to ensure that the site is compliant and audit ready at all times.
• Acts as a key influential leader, responsible for driving cross-functional audit support and audit readiness initiatives to improve quality systems, and overall organizational compliance to internal / external requirements.
• Ensures cross-functional partners and peers understand quality system requirements and how they impact product quality and regulatory compliance.
• Represents the site within Abbott through Corporate based community of practice as well as external Regulatory Intelligence Forums.
• Utilizes experience and knowledge gained from audits, internal assessments, and cross-business community of practice to proactively address potential compliance gaps.
• Responsible for oversight and administration of sites CAPA system and driving effective resolutions to identified issues.
• Responsible for tracking timeliness of change assessments for external requirements and associated metrics.
• Lead overall compliance lifecycle or similar programs within the site, collaborates with cross functional leadership, establishes effectiveness criteria, and advises Executive Management on the overall compliance status and audit readiness.

Responsibilities

Required Qualifications

Bachelors Degree in related field

Eight (8) years of Quality Systems, Quality Assurance and / or Regulatory Compliance / Affairs experience in medical device manufacturing or other similarly regulated environment. Knowledge of regulations and standards Such as MDD, MDSAP, MDR, NMPA and applicable US Code of Federal Regulations CFR 803, 806 and 820, ISO 13485 and 14971.

Five (5) years in a management capacity.

Preferred Qualifications

Prior experience in interfacing with Regulatory and Notified Bodies

Hands on experience with CAPAs

Experience with Supplier Quality

Understands applicability of Quality System Regulations

Excellent communication, leadership, and analytical skills

Detail-oriented with a strong focus on regulatory compliance.

Ability to work independently and as part of a team.

Strong problem-solving and decision-making abilities.

Proactive and able to manage multiple projects simultaneously.

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives : www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com / Abbott, and on Twitter @AbbottNews.

The base pay for this position is $127,300.00 $254,700.00. In specific locations, the pay range may vary from the range posted.