Staff Development Quality Engineer

Abbott; Pleasanton (CA); On-site; USD 114,000 - 228,000; Full time

Benefits offered by this job

Free medical coverage

Strong retirement plan

Tuition reimbursement

Education benefits

Global employer

Diversity recognition

Job summary

Abbott in Pleasanton, CA seeks an experienced Quality Engineer to independently or lead a project team across Design/Development Quality. You will manage design controls, risk management and verification/validation activities for new products while ensuring regulatory compliance.

The role emphasizes cross-functional collaboration, mentoring, and process validation support, with opportunities to influence product development in a globally respected healthcare company.

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.
• Is recognized as an expert in work group and across functions.
• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
• Has broad knowledge of various technical alternatives and their potential impact on the business.

Responsibilities

• Provide technical and quality system guidance for design controls.
• Develop strategy and lead delivery of team deliverables; coach on technical skills.
• Support design verification/validation per planning procedures.
• Lead meetings to prioritize and approve actions from issue resolution.
• Perform risk evaluation and management including FMEA and risk mitigation.
• Subject matter expert for statistical techniques; support sampling and analysis.
• Participate in reviews to ensure design plans and deliverables meet requirements.
• Represent QE in design output reviews and approvals.
• Support process validation; prepare protocols and reports.
• May assist product software development with cross-functional team.
• Apply best practices for requirements, verification, validation, user needs.
• Comply with FDA and other regulatory requirements and company policies.
• Maintain collaboration with cross-functional teams, especially R&D.
• Work as an individual contributor and mentor QE team members.

Skills

Design controls

Risk management

FMEA

Statistical methods

Quality system

Regulatory compliance

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 115,000 colleagues serve people in more than 160 countries.

Job Description

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

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.

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

The base pay for this position is $114,000.00 - $228,000.00. In specific locations, the pay range may vary from the range posted.