The Job requires a good knowledge and comprehensive understanding of the range of processes, procedures and systems to be used in carrying out assigned tasks and a basic understanding of the underlying concepts & principles upon which the job is based. The job requires the ability to make judgements based on practice and previous experience.
 This role will be a hybrid of Supplier Quality Engineer responsibilities and Manufacturing Quality Engineer responsibilities based on business need.

Preference in candidates will be given to those in and around the Cleveland OH area. 

Position Description (Principle Duties and Responsibilities) 

• Collaborates with suppliers to assure the quality of their products, materials, components and/or operations.
• Monitors supplier performance and supports efforts to develop and implement changes to improve the production process.
• Follows up with suppliers on quality deviations and ensures that solutions are identified and implemented.

Key Areas of Responsibility:

• Collaborates with cross-functional and suppliers' teams to address top quality issues.
• Own identified supplier driven non-conformances and manage the timely closure of NC's within Trackwise. Own or support identified supplier CAPAs and manage to timely root cause investigation, implementation and closure.
• Communicate & collaborate with suppliers regarding non-conformances, escalating supplier corrective action requests as required.
• Participates and may lead in the creation and/or review of new or modified procedures.
• Maintain KPIs for monitoring of supplier quality processes, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.
• Applies statistical methods of analysis and process control to external operations.
• Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
• Can work remotely, 25% Domestic Travel
• Lead quality issues with suppliers & partner with Internal Customers; Lead effective supplier containment and corrections/corrective actions
• Act as point of contact for Internal/ External Customer groups on key compliance issues related to assigned suppliers

Qualifications:

• BS in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Computer Engineering, or related Engineering degree. 
• Minimum 2 years of experience in quality engineering in a regulated environment. 
• Strong preference given to candidates with experience in new product development, focused on quality engineering-related activities. 
• Strong preference given to candidates with 4+ years of experience and with experience specific to the medical device industry. 
• Working knowledge of risk analysis methodologies, GD&T, PPAP, SPC, Root Cause Analysis, and Statistics. 
• Working knowledge of FDA QSRs, ISO 13485 and ISO 14971 standards. 
• Certified Quality Engineer (CQE) or other relevant ASQ certification preferred. 
• Six Sigma and/or Lean certifications preferred. 
• Class II/III medical device experience preferred.