Senior Development Quality Engineer

abbott; Menlo Park (CA); On-site; USD 90,000 - 180,000; Full time

Benefits offered by this job

Health Insurance" HIP PPO

Tuition reimbursement

Career development

Job summary

Abbott in Menlo Park (SH Structural Heart) seeks a Senior Quality Engineer to join the Development Quality team. You will provide Development Quality Engineering support to manufacturing and product development, ensuring the delivery of high-quality products to customers.

The role emphasizes leading quality improvement, designing validation test plans, and implementing risk analyses and CAPA within a regulated environment.

Qualifications

• Bachelor's degree in a related field or equivalent experience.
• Master's degree preferred.
• Minimum 5 years of related work experience in quality engineering.
• Experience in a regulated quality system environment.

Responsibilities

• Leads Product/Process improvement efforts by capturing quality metric data and performing analysis.
• Develops and executes Test Methods, Validation, Verification and Shelf Life protocols and reports.
• Creates Quality Tools & Training Materials and communicates them to teams.
• Develops product quality plans, quality specifications and risk analyses (FMEAs).
• Responsible for Risk Management activities including creating risk analyses and FMEAs.
• Develops and implements Process Monitoring Systems to reduce process variation and defects.
• Lead efforts to identify root causes and implement corrective and preventative actions (CAPA).
• Work with cross functional teams on continuous improvement initiatives.
• Ensure compliance with applicable regulatory requirements and standards.

Skills

Quality engineering

Risk management

CAPA

Regulatory knowledge

Education

Bachelor's degree in related area

Master's degree preferred

Tools

FMEAs

Process validation

Test methods

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 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

This position works out of our Menlo Park, CA location in the SH division.

Structural Heart Business Mission: why we exist

Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care

Our team in Menlo Park is looking for a Senior Quality Engineer in our Development Quality team. This role will provide Development Quality Engineering support to manufacturing and product development teams, helping to ensure delivery of highest quality product to the customer.

What You’ll Work On

• Leads Product/Process improvement efforts by identifying methods to capture quality metric data and by identifying & performing appropriate analysis methods to enhance sustaining product design and new product development.
• Develops and executes Test Methods, Test Method Validation, Design Verification and Shelf Life protocols and reports, Process Validation protocols and reports, Inspection and Control plans, Process Monitoring, and Risk Management activities.
• Creates Quality Tools & Training Materials by understanding the limitations of existing quality tools and training materials, by identifying & implementing more effective tools & materials, and by communicating new tools/materials to respective teams.
• Develops and implements product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other product development team members.
• Responsible for Risk Management activities including creating risk analyses and FMEAs.
• Develops and implements Process Monitoring Systems by identifying critical process and devising methods to reduce process variation in order to reduce/eliminate the cause of defects.
• Reduces and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by leading efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions.
• Participates in Corrective Action/Preventative Action (CAPA) process. May be responsible for identifying issues requiring data queries & bounding to implement complex product stops & develop release criteria.
• Works as part of a cross functional team on continuous improvement initiatives.
• Complies with and ensures compliance to applicable regulatory requirements and standards.

Required Qualifications

• Bachelors Degree in related area or an equivalent combination of education and work experience.
• Masters Degree preferred.
• Minimum 5 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.

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

$90,000.00 – $180,000.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

SH Structural Heart

LOCATION:

United States > Menlo Park : 3885 Bohannon Drive

WORK SHIFT:

Standard

TRAVEL:

Yes, 10 % 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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf