Quality Engineer I (Combination Products Manufacturing)

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:

We are seeking a high caliber Quality Engineer I for the Sylmar Operations Quality Engineering team. Each employee can make a difference and has the power, either individually or as a team, to continuously improve patient care and influence the success of the company. We are team-oriented, fast-paced, and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals. 

RESPONSIBILITIES

• 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.
• Implements and maintains the effectiveness of the Quality System.
• Takes initiative to increase quality engineering skills and stay current regarding industry technology and best practices to promote product and process quality.
• Participates in the design of products / specifications / processes / equipment / systems / facilities by applying standard engineering theories, concepts, and techniques, emphasizing risk management.
• Aware of potential defects and failure modes of the product.  Mitigates risks with controls.
• Assists in developing and executing process characterization and validation protocols; writes engineering reports with insightful charts and clear summaries. Completes paperwork timely and accurately.
• Efficiently learns the processes and procedures impacting component and/or product quality.
• 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. Seeks assistance for complex issues and exercises judgment within defined procedures and practices to determine appropriate action.
• Facilitates accurate and timely completion of device history and other quality records.
• Communicates effectively with outside resources, such as external test laboratories.
• Assists in the execution of statistical process control and monitoring of Critical To Quality (CTQ) parameters and specifications. 
• Prepares and gives presentations about product performance.  Identifies areas of risk with respect to compliance to internal and external requirements.  Offers multiple solutions to issues with clear advantages and disadvantages.
• Responds quickly to lead and manage manufacturing events involving non-conforming material, CAPA, manufacturing analysis, and internal customer signals.
• With team support, leads investigations, conducts design of experiments (DOE), gathers data, and performs preliminary analysis.
• Collaborates with cross-functional teams using various methodologies (e.g. Six Sigma and Lean Manufacturing) on how to modify existing processes to improve quality.
• Assists in planning and conducting small to medium-size engineering projects.  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.
• Interacts well with diverse groups to maintain strong working relationships.   Listens to and understands others' points of view and articulates tactfully and respectfully one's own perspective orally, in writing, and in presentations. Negotiates and reconciles differences to work well with others in a collaborative, fast-paced, goal-driven environment.
• Maintains regular and predictable attendance

QUALIFICATIONS

• Bachelor level degree in engineering, technical field, or equivalent (advanced degree preferred)
• 0-2 years engineering and/or technical operational experience plus demonstrated competence.  Advanced degree education may contribute towards the desired years of experience. 
• Technical background in combination products, medical devices, pharmaceutical, health care, nutritional products, laboratory diagnostics, or similar industries preferred.
• Basic knowledge of FDA, GMP, ISO 13485, and ISO 14971
• ASQ CQE, CSSGB and/or PMP certification preferred.
• Ability to travel approximately 10%, including internationally.

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES: