Staff Development Quality Engineer

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

Job summary

Abbott, a global healthcare leader, seeks an experienced Quality Engineer to independently lead project teams and support Design/Development Quality. You will guide design controls, risk management (FMEA and product risk analysis), and verification/validation activities for new products, ensuring compliance with FDA and global regulations.

In this role, you will mentor engineers, coordinate cross-functional teams, and drive best practices in quality systems, with an emphasis on robust process

Qualifications

• Bachelor's degree required; 9+ years in a related field.
• Expert in quality systems and across functions; broad knowledge of technical options.

Responsibilities

• Provide technical and quality system guidance related to establishing design controls requirements.
• Develop strategy and lead delivery of team or organization deliverables; mentor on technical skill.
• Support design verification and validation for new products; review protocols and reports.
• Lead meetings to prioritize and approve actions addressing issues in problem resolution systems.
• Perform risk evaluation and management activities including FMEA and risk analysis.
• Serve as SME for statistical techniques; support sampling and test activities.
• Participate in reviews to ensure design plans and outputs meet requirements.
• Support process validation; prepare/assist with protocols and reports.
• Possibly support product software development with cross-functional team.
• Drive best practices for establishing requirements and design verification/validation relative to user needs.
• Comply with US FDA regulations and other regulatory requirements.

Skills

FMEA

Product risk analysis

Regulatory compliance

Statistical methods

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:

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 forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical 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

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

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.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.

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.

JOB FAMILY:

Operations Quality

DIVISION:

HF Heart Failure

LOCATION:

United States > Pleasanton : 6101 Stoneridge Dr

WORK SHIFT:

Standard

TRAVEL:

Yes, 15 % of the Time

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf