Sr. Development Quality Engineer

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:

Summary:

• Individual contributor with comprehensive knowledge in specific area.
• Ability to lead and execute, in a timely manner, highly complex or specialized projects
• May make significant departures from traditional approaches to develop and implement solutions.
• Works closely with development/manufacturing/quality engineering to establish and ensure compliance with the quality system.
• Ability to act on their desire to make a difference, partner with others and put ideas into action.
• Actively engaged in a work culture that is team oriented, fast paced, accountable and progressive.

Main Responsibilities:

• Evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements.
• Investigates/troubleshoots validation problems for product performance and /or equipment processes.
• Conducts statistical analysis of test data and process anomalies
• Writes, reviews approves and/or executes documentation for new and current verification & validation procedures and technical reports related to equipment, product and/or processes.

• Ensures company's adherence to the established Quality System and GMP/ISO standards, including management of new product Design History Files.
• Works with Engineering, Marketing, Manufacturing, Clinical and Regulatory to establish measurable, valid product requirements.
• Aides in definition / validation of test equipment, as required to accomplish quality responsibilities.
• Develops and documents test plans, procedures, protocols and reports.
• Executes and / or reviews tests according to various protocol requirements.
• Assists in completion of Risk Management (including cybersecurity) activities, including Risk Analysis, Use & Design FMEA, Plans and Reports.
• Works with R&D engineering to devise Design Verification and Validation plans for products based on performance specifications and risk analysis.
• Analyzes and communicates product test results / conformance to specifications and standards.
• Conducts technical and statistical investigations concerning optimization to specification and compliance to specification.
• Assists in definition and completion of in vitro testing including applicable animal studies.
• Assists in defining and measuring process capability, process controls, and process validation; assists in definition of Critical to Quality (CTQ) parameters.
• Aides in definition of supplier quality specifications, sampling plans, and vendor qualification.
• Assists in specifications and testing of sterilization methods.

Qualifications:

• Bachelors Degree, Engineering or related field and 5 Yrs (min.) experience
• Experience in Quality Engineering and demonstrated use of Quality tools/methodologies
• Prior medical device experience and experience with product hardware
• Product software experience is preferred.
• Detailed knowledge of FDA-21CFR820, GMP, and ISO 13485.
• Work effectively with cross-functional team members, utilizing effective time management skills.
• Leadership skills, including demonstrated ability to lead Quality function in multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
• Advanced computer skills, including statistical/data analysis (ie: Minitab) and report writing skills.
• Solid communication and interpersonal skills.
• Device & Non-Device Software validation experience preferred.
• Risk Management (including Cybersecurity) process experience preferred.

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