Quality Engineer II (Electro-Mechanical)

Job description

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.

JOB DESCRIPTION:

Position Summary

An engineering professional who applies scientific knowledge, engineering knowledge, mathematics, and ingenuity to complete assignments related to a specific technical field or discipline.

Main Responsibilities

• Lead and manage discrepant material processes, including nonconforming material report, CAPA, manufacturing analysis, and internal customer signals.
• Responsible for improving quality procedures and methods, implementing quality techniques, testing products, and compiling/evaluating statistical data to monitor quality levels.
• Train others on processes and procedures impacting component and/or product quality.
• Complete paperwork timely and accurately.
• Support and execute verification/validation activities including IQ, OQ, PQ, IMV/TMVs
• Performs risk assessment including DFMEA, PFMEA
• Prepare charts and write summaries about how well product conforms to existing standards.
• Offer suggestions to others on how to modify existing process or procedures to improve quality.
• Responsible for implementing and maintaining the effectiveness of the Quality System.

Project Management

• Plans and conducts small- to medium-size assigned projects within engineering specialty requiring conventional types of plans, investigations, and/or equipment.
• Participates in economic analysis and feasibility studies related to project alternatives.
• Jointly responsible for achieving the project's financial targets in support of business objectives.

Technical / Design

• Keeps aware of the changing technical and competitive environment as it relates to the business.
• Establishes a means of keeping abreast with technology on own engineering area and sharing with co-workers, e.g. stays current in product/process innovations in areas of expertise.
• Participates and/or assists other engineers in the design of products/processes/equipment/systems/facilities by applying standard engineering theories, concepts, and techniques within the discipline.
• Investigates, conducts tests or experiments, gathers data, and performs preliminary analysis.
• Prepares and communicates recommendations and respective action plans.
• Independently executes the design of products/processes/equipment/systems/facilities by applying standard engineering theories, concepts, and techniques within the discipline
• Independently investigates, conducts tests or experiments, gathers data, and performs preliminary analysis.

Compliance

• Complies with all regulations and standards for quality, Environmental, Health, Safety, and Energy (EHS&E) Global Policies, Abbott Engineering Standards, and other governance areas as applicable.
• Ensures quality and effectiveness of assigned tasks.
• Has awareness of the potential consequences (defects and failure modes) of design changes to established processes.
• Identifies areas of risk with respect to compliance.

ADDITIONAL RESPONSIBILITIES MAY INCLUDE:

• Coordinates with technical support personnel to conduct prototype or experimental runs of products or processes.
• Directs the efforts of others such as technicians and outside resources. - Performs tasks such as writing Requests for Capital Expenditures (RCEs), safety/quality checklists, scope documents, etc.
• Develops and executes validation protocols.

Accountability

• Recognizes risks versus the relative gains associated with actions; understands projects critical success factors in own sphere, e.g. makes decisions regarding purchases, evaluating budget concerns against schedule; matches design specifics with respect to system performance.
• Responsible to meeting established objectives and goals.
• Drives functional performance that ensures the highest standard in quality, customer service, and regulatory compliance are met.

Qualifications

• Bachelor's Degree (Electrical/Mechanical Engineer, science or closely related discipline is preferred), or equivalent technical experience plus demonstrated competence, with a desired 2+ years of significant engineering and/or operational experience. Additional post-graduate education may contribute towards the desired years of experience.
• Mechanical or Electrical Engineering experience is preferred.
• Medical Device background is preferred.
• Quality Engineering experience is required.
• Has demonstrated competency within a discipline.
• Possesses a working technical knowledge and application of concepts, practices, and procedures. Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action.
• Interacts well with diverse groups within engineering and maintains strong working relationships with internal and external collaborators.
• Listens to and understands others' points of view and articulates tactfully and respectfully one's own perspective orally, in writing, and in presentations.
• Works well with other engineers in a collaborative, fast-paced goal-driven environment.
• Possesses interpersonal skills to negotiate and reconcile differences.
• Has a technical background in health care, medical devices, pharmaceutical, or similar industries (preferred).

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