Senior Engineer Quality Systems

United States - Texas - Irvingsenior

OtherEngineer

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Quick Summary

Overview

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,

Technical Tools

OtherEngineer

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 122,000 colleagues serve people in more than 160 countries.

What We Offer

~2 min read

✓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 with 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). Mentor lower-level CAPA engineers.

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

✓Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Requirements

~1 min read

Bachelor’s in electrical or technical field, or an equivalent combination of education and work experience.
Minimum 4 years experience.

Masters degree a plus
4-8 years technical experience.
Previous Quality experience and demonstrated use of Quality tools/methodologies.
Detailed knowledge of FDA, GMP, and ISO 13485.
Demonstrated and impactful project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality system related issues in a timely and effective manner.
Advanced computer skills, including gap analysis and report writing skills.
Prior medical device experience preferred,
Six Sigma certification or Lean Manufacturing experience preferred. ASQ CQE, CQA
preferred certification.
Experience working in a broader enterprise/cross-division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to travel, including internationally.

Apply Now

Operations Quality

TM Transfusion Medicine

United States > Irving : LC-02

Standard

Yes, 10 % of the Time

Not Applicable

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Work requiring repeated bending, stooping, squatting or kneeling

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Location & Eligibility

Where is the job

United States - Texas - Irving

On-site at the office

Who can apply

Same as job location

About this job

Pay per year: $78,000–$156,000 a year; 25% below the $155,000 median for Engineer jobs on Jobera (1,464 salaries).
Posted: 11 days ago
Employer: has 4,359 open jobs on Jobera in 26 countries.