Staff Quality Engineer

Abbott Laboratories; California (MO); On-site; USD 114,000 - 228,000; Full time

Benefits offered by this job

HIP PPO health plan

Retirement plan with high employer 100

Tuition reimbursement

Job summary

Abbott is seeking an experienced Supplier Quality Engineer for the SH Structural Heart division in Santa Clara, CA. You will drive development and qualification of implantable valve components and oversee supplier quality programs.

You will ensure process validation, collaborate with suppliers and manufacturing, and apply statistical methods to maintain compliance with FDA/GMP/ISO standards. Travel about 10% is expected.

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, ISO 22442.
• Solid communication and interpersonal skills.
• Advanced computer skills, including statistical/data analysis and report writing.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to travel approximately 10%.

Responsibilities

• 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 support 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 and supplier performance.
• Provides engineering guidance to Abbott Receiving Inspection including statistical analysis and Gage R&R studies.
• Assesses supplier capabilities through direct visits, technical discussions, and testing.
• Collaborates with suppliers to develop comprehensive process validation strategies.
• Proactively communicates quality issues to suppliers through corrective action requests and data-driven discussions.
• Leads investigation and permanent resolution of supplied component nonconformances.
• Responsible for Supplier Performance and Evaluation.
• Evaluates and develops data agreements, skip lot, dock-to-stock, CoC, and CoA partnerships with suppliers.
• Applies engineering analysis to reduce the need for inspection in line with program policies.

Skills

Engineering experience

FDA knowledge

GMP knowledge

ISO 13485

Statistical analysis

Communication skills

Team collaboration

Education

BS in Engineering or Technical Field

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 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

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

• 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)

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: 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 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.

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