Jobs in Santa Clara, CA (Now Hiring) — 4,388 open at 466 companies — Page 35
Abbott
Staff Quality Engineer
Santa Clara, California, United States · On-site
$114k–$228k/yr
Senior$20B raised
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The Staff Quality Engineer acts as the site interface to suppliers, driving the development, maintenance, and improvement of quality for implantable heart valve components. Responsibilities include conducting supplier audits, managing nonconformances, and collaborating on process validation strategies to ensure compliance with regulatory standards.
Requirements
Candidates must possess a Bachelor's degree in Engineering or a technical field and at least 7 years of relevant engineering experience. Detailed knowledge of FDA, GMP, and ISO quality standards is required, along with strong statistical analysis and interpersonal skills.
Full 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
This position works out of our Santa Clara, 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.
What You’ll Work On
We are seeking an experienced, high caliber Staff Supplier Development Quality Engineer to be responsible to act as the site interface to suppliers. Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.
Drives the development, maintenance and improvement of quality of implantable heart valve components sourced from outside suppliers.
Reviews new heart valve components specifications and proposes changes to existing specifications to support component quality and manufacturability.
Develops all supplied component quality plans to drive component qualification throughout the lifecycle of the design.
Manages development of supplied product inspection procedures and first article requirements.
Responsible for Supplier Quality activities such as: Supplier Audits, Supplier performance, etc.
Provides engineering guidance to Abbott Receiving Inspection including statistical analysis, measurement techniques, and Gage R&R studies.
Assesses supplier capabilities through direct visits, technical discussions, and directed testing.
Collaborates with suppliers to develop comprehensive process validation strategies.
Proactively communicates quality issues to suppliers as needed through supplier corrective action requests, data driven and technical discussions.
Leads the investigation, permanent resolution and prevention of supplied component nonconformances.
Responsible for Supplier Performance and Evaluation.
Evaluates and develops Supplied Data Agreement, Skip Lot, Dock-to-Stock, CoC, and CoA partnerships with suppliers.
Applies thorough engineering analysis and judgement to reduce the need for inspection in accordance to program policies and data gathered.
Works with Manufacturing Engineering to assess and address supplied component issues.
Applies systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Participate in or lead teams in supporting Supplier Quality program requirements (e.g., represent the Supplier Quality function as a Core Team Member).
Mitigates risk by work in partnership with the suppliers to document Process Flow Charts, PFMEAs, and Control Plans.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Performs other related duties and responsibilities, on occasion, as assigned.
Required Qualifications
BS degree in Engineering or Technical Field or equivalent experience; advanced degree preferred
7+ years’ Engineering experience and demonstrated use of Quality tools/methodologies
Detailed knowledge of FDA, GMP, ISO 13485, ISO 14971, and ISO 22442
Solid communication and interpersonal skills
Advanced computer skills, including statistical/data analysis and report writing skills
Ability to work in a highly matrixed and geographically diverse business environment
Ability to work within a team and as an individual contributor in a fast-paced, changing environment
Ability to leverage and/or engage others to accomplish projects
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
Multitasks, prioritizes and meets deadlines in timely manner
Strong organizational and follow-up skills, as well as attention to detail
Ability to travel approximately 10%
Ability to maintain regular and predictable attendance
Preferred Qualifications
Training and/or Certification to ISO 22442
Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
Prior medical device (implantable) manufacturing experience preferred but not necessary.
Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
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.
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
SH Structural Heart
LOCATION:
United States > Santa Clara : Building A - SC
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 10 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)
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, nutritional and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and www.facebook.com/AbbottCareers, on Instagram @AbbottGlobal, and on X @AbbottNews.
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.
Terms of Use: https://www.abbott.com/social-media-terms-of-use.html
Privacy Policy: https://abbo.tt/privacy
Offices: 100 Abbott Park Road, Abbott Park, Illinois 60064-3500, US