Staff Development Quality Engineer

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

Job summary

Abbott in Pleasanton, CA is seeking a senior quality/validation professional to lead design controls and development quality efforts. Independently or with a project team, you will plan and execute risk-based quality programs, coordinate with R&D and manufacturing, and ensure compliance with FDA regulations.

You will review protocols, reports, and validation plans, drive verification and validation activities, perform FMEA and risk analyses, and mentor QE staff.

Qualifications

• Bachelor’s Degree (required).
• Minimum 9 years of related work experience with a complete understanding of the functional area.
• Comprehensive knowledge of a technological field.
• In-depth knowledge of business unit functions and cross-group dependencies.
• Recognized expert within work group and across functions.
• Experience in a quality system environment.
• Awareness of governmental regulations and compliance requirements.
• Ability to solve complex problems with analytical evaluation.

Responsibilities

• Independently or lead a project team to support Design/Development Quality.
• Provide guidance on establishing design controls requirements and strategy.
• Lead execution of deliverables and mentor on technical skills.
• Support design verification and validation activities for new products and review protocols/reports.
• Lead meetings to prioritize and approve action plans addressing issues.
• Perform risk evaluation and management (FMEA, risk analysis).
• Serve as SME for statistical techniques and support sampling/analysis activities.
• Participate in reviews to ensure design plans and outputs are met.
• Represent QE in review/approval of design outputs and validation protocols.
• Support process validation activities and cross-functional collaboration.
• Ensure compliance with FDA regulations and company policies.

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.

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

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

The base pay for this position is $114,000.00 – $228,000.00

JOB FAMILY: Operations Quality DIVISION: HF Heart Failure LOCATION: United States > Pleasanton : 6101 Stoneridge Dr ADDITIONAL LOCATIONS: 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

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well‑being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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

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

Follow Us: Facebook LinkedIn YouTube Twitter