Abbott Quality Systems Engineer II in Plano, Texas
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
The Quality Engineer II, Quality Systems is an individual contributor primarily responsible for managing and maintaining the product and Quality Management System (QMS) regulations and standards management system, and contributing to the maintenance of the QMS. Work requires the understanding and application of standards, theoretical principals, understanding of the product development lifecycle, using creative and analytical techniques, and effective communication.
Job Duties & Responsibilities:
Manages, maintains, and improves processes related to the compliance of regulatory standards management system.
Exercises judgment in planning, organizing, performing, and/or coordinating projects by working with internal customers (e.g., Regulatory Affairs, Quality, Engineering, and Upper Management) This position is responsible for developing and maintaining quality system elements and providing quality system support within Abbott organizations.
Identifies and routinely uses the most effective and efficient methods (i.e., best practices) to execute processes; continually evaluates their effectiveness and appropriateness. Follows the tracking of product and QMS standards and regulations implementation throughout the entire lifecycle.
Provides Quality System Body of Knowledge support to organization.
Identifies changes to regulations and standards, which may affect Quality System or product, and coordinates activities needed to ensure compliance
Supports audit preparation and backroom activities.
Investigates, and resolves system nonconformances (defined during internal and/or external audits).
Develops QS related reports (e.g., quality plans & reports, process documentation, gap assessments) to support business activities
Ensures compliance to ISO 13485 & 21 CFR 820 Quality System Regulations by providing input to interpretation of regulations, performing gap analyses, and leading activities to implement improvements.
As appropriate, identify improvement opportunities in quality system compliance (device and process) and utilize quality tools to implement process improvements to enhance product quality and reduce process variance.
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, lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality System function as a Team Member)
Facilitates core Quality System activities (e.g. Management Review preparation, External Standards, Org Responsibility, Quality Manual) to meet process requirements
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Completes tasks related to internal/external audit preparation and execution as needed
Tracks Quality status of quality records and facilitate their timely closure
Support all Abbott initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), Learning Management Systems (LMS) and other regulatory requirements
Comply with U.S. and international regulations for medical devices, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
Performs other related duties and responsibilities, on occasion, as assigned
Bachelor’s degree in an engineering or scientific/technical discipline
2+ years of related experience, preferably in an FDA-regulated industry (e.g., medical device, pharmaceutical, biotech)
Solid communication and interpersonal skills
Ability to maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Strong organizational and follow-up skills, as well as attention to detail
Ability to multitask, prioritize and meet deadlines in a timely manner
Familiarity with Microsoft Word, Excel, PowerPoint, and Visio or equivalent office suite software
Strong analytical and problem solving skills, and demonstrated capacity for accuracy
Ability to query databases and refine data into summarized results
Advanced computer skills, including statistical/data analysis and report writing skills
Ability to maintain regular and predictable attendance
Ability to comply with Abbott corporate policy which prohibits the use of products containing tobacco on Abbott property
Certification (e.g., ASQ) or training in relevant Quality disciplines such as Quality Engineering, Auditing, or Six Sigma
Training in QMS requirements (e.g., FDA QSR 21 CFR 820; ISO 13485)
Experience auditing Quality Management Systems or elements thereof
Experience implementing process improvement methodologies (e.g., Six Sigma, Lean).
Engineering, change control, and project management experience
CAPA root cause analysis and resolution, and audit NC remediation experience
Knowledge of Quality tools/methodologies
Experience working in a broader enterprise/cross-division business unit model
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 leverage and/or engage others to accomplish projects
Strong verbal and written communication skills with ability to effectively communicate at multiple levels in the organization
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
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com