Staff Quality Engineer

Abbott; Santa Clara (CA); On-site; USD 114,000 - 228,000; Full time

Benefits offered by this job

Free medical coverage

Competitive retirement plan

Tuition reimbursement

Job summary

Abbott in Santa Clara, CA is seeking a Senior Supplier Quality Engineer to lead the development and qualification of implantable heart valve components sourced from outside suppliers.

You will drive supplier quality plans, audits, data analysis, and corrective actions in a fast-paced medical device environment, ensuring compliance with FDA, ISO 13485 and GMP standards.

Join a team that partners with manufacturing and suppliers to deliver safe, high-quality products that improve patient outcomes.

Qualifications

• BS degree in Engineering or Technical Field; advanced degree preferred
• 7+ years’ engineering experience with quality tools/methodologies
• Detailed knowledge of FDA, GMP, ISO 13485, ISO 14971, ISO 22442
• Strong communication and interpersonal skills
• Advanced computer skills including statistical/data analysis and report writing

Responsibilities

• Drives the development, maintenance and improvement of quality of implantable heart valve components sourced from outside suppliers.
• Reviews new heart valve component specifications and proposes changes to support quality and manufacturability.
• Develops all supplied component quality plans to drive qualification throughout the design lifecycle.
• Manages development of supplied product inspection procedures and first article requirements.
• Responsible for Supplier Quality activities such as supplier audits and performance.
• Provides engineering guidance to Abbott Receiving Inspection including statistical analysis and Gage R&R.
• Assesses supplier capabilities through visits, discussions and testing.
• Collaborates with suppliers to develop comprehensive process validation strategies.
• Proactively communicates quality issues to suppliers through corrective actions and data-driven discussions.
• Leads investigation and permanent resolution of nonconformances.
• Evaluates supplier data agreements and CoC/CoA partnerships.
• Applies systematic problem-solving to reduce inspection needs per program policies.
• Works with Manufacturing Engineering to address supplied component issues.
• Participates in or leads teams for Supplier Quality program requirements.
• Mitigates risk by documenting PFMEAs and Control Plans with suppliers.
• Complies with FDA regulations and ISO standards, policies and procedures.
• Maintains positive communications with all stakeholders and vendors.
• Performs other related duties as assigned.

Skills

Quality tools

Statistical analysis

Regulatory knowledge

Communication

Team player

Education

BS in Engineering

Advanced degree preferred

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.

Working at Abbott

• 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

• 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.

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 $114,000.00 – $228,000.00. In specific locations, the pay range may vary from the range posted.