Senior Engineer Supply Development Quality

The Opportunity

Supplier Development Quality Engineer 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.
• May provide coaching, and mentoring for technical team personnel.
• 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).
• 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.

Required Qualifications

• Bachelor's Degree in a relevant field
• Minimum of five (5) years of relevant experience in a medical device or pharmaceutical field
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
• 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
• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
• CAPA Experience

Preferred Qualifications

• Masters Degree
• Experience working in a broader enterprise/cross-division business unit model preferred
• ASQ CQE or other certifications preferred
• Prior medical device experience