Senior Engineer Quality Systems

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!

• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

• 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.

The Opportunity

The person hired in this role will be an established professional with the necessary skills to perform Senior Engineer Quality Systems activities in support of ARDx IT systems. This position is responsible for developing and maintaining quality systems and providing quality system support for ARDx IT.

What You’ll Work On

This role supports IT internal and external audits, quality and compliance operations. This is a hands-on role, which will suit a self-starter.

• Supports all phases of quality and compliance audits of IT systems audits from audit readiness to observation evaluation, to follow-up and remediation in cooperation with the responsible BRMs and their teams.

• Provides Quality System Body of Knowledge support to Division and organization.

• Collect and analyze quality data as needed for monthly metrics and data driven recommendations based on trends.

• Investigates, and resolves quality system nonconformance’s (defined during internal and/or external audits.

• Communicate confidently and effectively with all levels of management, peers and key stakeholders, including timely escalation of quality issues.

• Ensures compliance to ISO 13485, 21CFR 820 Quality System Regulations, and other applicable regulations and standards by providing support for interpretation of regulations, performing gap analysis, and leading activities to implement improvements.

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

• As appropriate, utilizes Lean, Six Sigma, and other quality tools to implement process improvements to enhance product quality and reduce process variance by identifying improvement opportunities in divisional quality system compliance, device, and process.

• Analyzes quality audit findings and recommends modifications in products or standards. Proactively identifies opportunities for system compliance improvement and leads activities to implement improvements.

• As appropriate, participates in or leads teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality System function as a Team Member).

• Functions as a senior CAPA engineer.

• Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS)and other regulatory requirements.

• Complies with medical device regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  

• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

• Experience in having solid communication and interpersonal skills.

Required:

• Bachelor’s Degree in Management Information Systems, Computer Science, Business Administration, or another discipline relevant to IT and the Healthcare industry. Or the equivalent of years of experience and education combined with HS diploma.

• Minimum of 4 years of experience in IT quality, compliance, or equivalent combination of education and work experience.

• Previous Quality experience and demonstrated use of Quality tools/methodologies.

• Detailed knowledge of FDA, GMP, and ISO 13485.

Preferred:

• 3 or more years of quality and regulatory compliance experience with healthcare, medical diagnostics, or similar experience.

• Knowledge of quality management systems (QMS), quality management review (QMR), hosting and supporting quality audits, supplier management, training management, CAPA knowledge and demonstration of understanding of computerized software life cycle including privacy and cybersecurity aspects.

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

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 and @AbbottGlobal.

The base pay for this position is $71,300.00 – $142,700.00. In specific locations, the pay range may vary from the range posted.

• quality system compliance
• quality systems
• quality management systems
• capa
• product quality
• quality management
• quality tools
• regulatory compliance
• cybersecurity
• 21cfr
• supplier management
• quality audit
• compliance operations
• gap analysis
• computer science
• interpersonal skills
• fda
• audit readiness
• six sigma
• divisional management
• diagnostics
• qms
• regulatory requirements
• gmp