MAIN PURPOSE OF ROLE

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

Provide Quality support to manufacturing, helping to ensure delivery of the highest quality product to the customer. Provide support to Development /Improvement teams for new or existing products.

Ensure that activities are performed and documented per systems and procedure in accordance with Abbott Policies and applicable Quality And Regulatory Requirements.

MAIN RESPONSIBILITIES

• Apply quality principles, analyzes quality records, prepares reports and recommends improvements.

• Conduct inspection, verification and validation of components or materials used in development processes.

• Identify and address recurring problems either with the quality of the product or the reliability of testing procedures.

• Interfaces primarily with internal company contacts.

• Plans and conducts small size assigned projects within engineering specialty requiring conventional types of plans, investigations, and/or equipment.

• Investigates, conducts tests or experiments, gathers data, and performs preliminary analysis. Reports findings. Prepares and communicates recommendations.

• Builds relationships. Initiates and cultivates open, honest relationships with colleagues, developing an understanding of others’ needs.

• Identifies and Evaluates areas of risk with respect to compliance, Product/Mfg performance, Develops procedures, maintain FMEAs.

• Resolves problems, such as production process deviations, non-conformances (CAPA).

• May work in combination with SQE and Receiving Inspectors focused on driving improvements and CAPA in the quality of components sourced from outside suppliers.

• Provides technical support in the supplier corrective action, manufacturing yield and field failures.

• Identifies and Evaluates areas of risk with respect to compliance, Product/Mfg performance, Develops procedures, maintain FMEAs.

QUALIFICATIONS

EDUCATION:

• Bachelor’s degree in Engineering, science or closely related discipline is desired, or equivalent technical.

• Minimum 80% of bachelor’s degree completed and at least 1 year of experience in manufacturing or quality in the medical device industry, or Bachelor’s degree completed and experience is a plus

• 1 year of experience in medical device or related industries if bachelor’s degree has not been completed, only required if 80% of bachelor’s degree completed

• Intermediate commands of English / Required

PREFERRED QUALIFICATIONS AND EDUCATION:

• Quality background desired

• FDA/ISO regulations knowledge desired

• Static's knowledge desired

• Personal skills needed include accountability, nimble learning, diligence, resourcefulness , customer focus, effective communication skills

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