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 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 122,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

Main Purpose: Independently or lead a project team of supervisors/engineers/technicians, to support Design/ Development Quality. Identify, plan and conduct projects requiring a combination of conventional and custom risk-managed execution plans as well as design controls deliverables, manages multiple often concurrent projects.

What You'll Work On

• 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. This includes, but is not limited to, review and approval of protocols and reports, review of development plans, and review of other system and software documentation.
• Leads meetings to prioritize, review and/or approve of 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. Represent the quality engineering function for the review and approval of designated design outputs.
• 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.

Required Qualifications

• Bachelor's Degree.
• Minimum 9 years of related work experience with a complete understanding of specified functional area.
• Comprehensive knowledge of a particular technological field. Uses in-depth knowledge of business unit functions and cross group dependencies/ relationships.
• Is recognized as an expert in work group and across functions. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
• Has broad knowledge of various technical alternatives and their potential impact on the business.

Preferred Qualifications

• Master's Degree

Abbott is an Equal Opportunity Employer, committed to employee diversity.