Quality Systems Engineer II

Job description

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 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

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) to classify product and QMS standards and regulations, and establish change management commensurate with risk and requirements
• 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. Develops, generates, and distributes periodic status reports on issuance of, and compliance to, new and revised product and QMS standards and regulations; this includes identification of and reporting of metrics against goals for Quality reviews (e.g., Management Review)
• 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
• 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)
• As appropriate, lead in the completion and maintenance of risk analysis, as related to quality systems.
• 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
• Complete tasks related to internal/external audit preparation and execution as needed
• Track Quality status of quality records and facilitate their timely closure
• Other Duties:
• 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

General Qualifications:

• Bachelor's degree (BS preferred) in an engineering or scientific/technical discipline
• 2-4 years of 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

Preferred Qualifications:

• 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

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