Senior Supplier Quality Engineer

The Opportunity

This position works out of our Minnetonka, MN location in the Cardiac Rhythm Management division.

As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.

Senior Supplier Quality Engineer is responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection.

Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet company and regulatory requirements.

What You’ll Work On

Contributes to the development, maintenance and improvement of division supplier development quality program policies, procedures and forms.

Provides work direction, coaching, and mentoring for technical team personnel (including engineers and technicians)

Provides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers in applying program requirements.

Reviews and approves all supplied product drawings and component quality plans.

Manages development of supplied product inspection procedures and first article requirements.

Provides engineering guidance to division Receiving Inspection including statistical analysis, measurement techniques, Gage R&R studies and inspection procedures.

Assesses supplier capabilities through direct visits, technical discussions, directed testing and quality system audits.

Proactively communicates quality issues to suppliers as needed through supplier quality system audits, supplier corrective action requests and technical discussions.

Participates and provides engineering ownership for all supplied product Non-Conforming Material Reviews.

Contributes and participates in supplier performance reviews.

Evaluates and develops Supplied Data Agreement partnerships with suppliers.

Applies sound engineering analysis and judgment to reduce the need for inspection in accordance to program policies.

Works with Manufacturing engineering to assess and address purchased product issues.

Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Design and conduct experiments for process optimization and / or improvement

Participate in or lead teams in supporting Supplier Development Quality program requirements (e.g., represent the Supplier Development Quality function as a Core Team Member)

Provide leadership and supplier interface support for Supplier Corrective Actions, Supplier Change Requests and other related issues.

Lead and support supplier quality audits

Lead the development and execution of quality improvement projects.

Other tasks as assigned.

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.

EDUCATION AND EXPERIENCE YOU’LL BRING

Bachelor’s Degree Engineering or Technical Field OR an equivalent combination of education and work experience

Master’s Degree Advanced degree preferred.

Minimum 5 years’ experience.

Prior medical device experience preferred.

Demonstrated supervisory experience 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. Strong 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.

Advanced computer skills, including statistical / data analysis and report writing skills. Experience implementing various product and process improvement methodologies (e.

g., Six Sigma and Lean Manufacturing). ASQ CQE or other certifications preferred.

Experience working in a broader enterprise / cross-division business unit model preferred. 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.

Ability to travel approximately 10-20%, including internationally (only if required).