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Abbott Senior Supplier Development Quality Engineer in Santa Clara, California

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 107,000 colleagues serve people in more than 160 countries

We are seeking an experienced, high caliber Senior 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.

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.

For years, Abbott’s Medical Device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine finger sticks.

Job Responsibilities:

Drives the development, maintenance and improvement of quality of Catheter Delivery System components sourced from outside suppliers.

Reviews Catheter Delivery System component 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 Catheter Delivery System 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.

Requirements:

BS degree in Engineering or Technical Field or equivalent experience; advanced degree preferred

Engineering experience and demonstrated use of Quality tools/methodologies

Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971

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 25%

Ability to maintain regular and predictable attendance

Preferred:

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

5+ years’ experience

Prior medical device manufacturing experience preferred but not necessary.

Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)

What we offer:

At Abbott, you can have a good job that can grow into a great career. We offer:

  • Training and career development , with on-boarding programs for new employees and tuition assistance

  • Financial security through competitive compensation, incentives and retirement plans

  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

  • Paid time off

  • 401(k) retirement savings with a generous company match

  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities

*Learn more about our benefits that add real value to your life to help you live fully: * www.abbottbenefits.com at http://www.abbottbenefits.com/pages/candidate.aspx

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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