Quality Manager

Working At Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll 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 high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
• A company recognized as a great place to work in dozens of countries around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

This position works out of our Pleasanton, CA location in the Heart Failure Division. In Abbott's Heart Failure (HF) business, we're developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.

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

What You'll 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 the overall Audit Readiness program for the site and drive 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.
• 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 site CAPA system and driving effective resolutions to identified issues.

Key Responsibilities

• Provide leadership to maintain Quality Management System compliance for Abbott Heart Failure Pleasanton site.
• Oversee site's compliance lifecycle and CAPA System.
• Lead site's CAPA program and drive continuous improvements by providing strategic direction for robust CAPA investigations and implementation of resolutions while ensuring sustainability and effectivity.
• Serve as the primary interface with external regulatory bodies, manage internal and external inspections and overall audit strategies.
• Drive key readiness initiatives utilizing risk-based prioritization and mitigation to maintain an audit ready status.
• Evaluate and monitor the results of external and internal audits. Report the audit results to management and status/execution of corrective actions associated with the audit results.
• Analyze trends from various sources and proactively address regulatory, compliance, and quality issues.
• Actively participate in FDA inspections and lead internal/corporate audits, notified body audits and applicable external certification audits including any post-audit responses.
• Maintain data analysis requirements for applicable Quality System metrics and Quality Management Reviews (QMRs).
• Lead, guide and retain a diverse, highly qualified staff and provide ongoing performance feedback. Set goals which align to business plans and manage the execution of goals through coaching and mentoring. Maintains a safe, enthusiastic, and professional work environment.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Required Qualifications

• Bachelors Degree in a scientific or technical discipline or an equivalent combination of education and work experience
• 5-7 years of experience in function or related field.
• Two (2) 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.
• Two (2) years in a leadership / supervisory role.

Preferred Qualifications

• Prior experience in interfacing with Regulatory and Notified Bodies
• Hands on experience with CAPAs
• 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.

The base pay for this position is $112,000.00 $224,000.00. In specific locations, the pay range may vary from the range posted.