Lead Staff Development Quality Engineer

Abbott (abbottcareers2 board); United States; On-site; USD 110,000 - 150,000; Full time

Job summary

Abbott is seeking an experienced Quality Engineer to independently lead design/development quality efforts across medical devices. The role focuses on establishing design controls, risk management, and verification/validation activities in a regulated environment.

You will collaborate with R&D, manufacturing, and regulatory teams, provide SME guidance on statistical methods, and ensure compliance with FDA and other regulations while driving continuous improvement.

Qualifications

• Bachelor's Degree.
• Minimum 9 years of related work experience.
• Comprehensive knowledge of a particular technological field.
• Is recognized as an expert in work group and across functions.
• Works on complex problems requiring in-depth evaluation of factors.
• Has broad knowledge of various technical alternatives and their impact on the business.

Responsibilities

• Provide technical and quality system guidance related to establishing design controls requirements.
• Development of strategy and leading execution of deliverables for the team or organization and coaching/ mentoring on technical skill on the subject matter.
• Supports design verification and validation activities for new products in accordance with design planning procedures.
• Leads meetings to prioritize, review and/or approve action plans for addressing issues captured in problem resolution systems during development.
• Performs risk evaluation and associated management activities related to product development including FMEA, product risk analysis, and mitigation of failure modes.
• SME for statistical techniques and can provide cross-functional support to develop, update additional sampling and analysis activities as well as test of comparison.
• Participates in technical and management reviews to ensure design plans, product design and deliverables related to product development are met.
• Supports process validation by assessing the need for validation and preparing and/or supporting protocols, reports and other documentation as required.
• May be involved with supporting product software development activities in conjunction with a cross-functional team.
• Drive best practices for establishing requirements and completing design verification and validation especially as it relates to user needs.
• Complies with US FDA regulations, other country regulatory requirements, company policies, and procedures.
• Maintains a strong, collaborative partnership with cross functional team members especially with R&D.
• Works as an individual contributor and may provide guidance or oversee work of other QE team members.

Skills

Quality engineering

Risk management

Statistical techniques

Design controls

Cross-functional collaboration

Education

Bachelor's Degree

Master's Degree

Job description

Abbott is seeking an experienced Quality Engineer to independently lead design/development quality efforts across medical devices. The role focuses on establishing design controls, risk management, and verification/validation activities in a regulated environment.

You will collaborate with R&D, manufacturing, and regulatory teams, provide SME guidance on statistical methods, and ensure compliance with FDA and other regulations while driving continuous improvement.