Staff Quality Engineer

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)

Apply Now

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.

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