Senior Supplier Quality Engineer

Senior Supplier Quality Engineer

The Senior Supplier Quality Engineer drives improvement and corrective action in the quality of direct components from external suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures.

Your responsibilities will include:

• Assess potential new suppliers for technical, quality and manufacturing capabilities. Provides technical support for the introduction of components from a new supplier.
• Generates and maintains incoming inspection procedures - trains inspectors to these procedures.
• Analyzes incoming material defects, dispositions and drives corrective action as necessary. Communicates issues to suppliers.
• Investigates field failures related to supplier materials. Develop corrective action plan where necessary.
• Ability to influence cross functional global teams spanning Design Quality Assurance, R&D, Regulatory, Supplier Engineering, and Sourcing.
• Anticipates potential barriers to success as well as needed resources, sees alternatives to overcome obstacles, and avoids near misses
• Mentors others in understanding of core Supplier Quality Engineering skills/competencies (Supplier Compliance, Change Control, VIP, Statistical aptitude, Quality Tools application)
• Partners with suppliers on process improvements for capability, reduction in risk, single point failures, etc.
• Generates ideas on how to expand the impact of commodity teams from cross-network customers. Understands the effects of industry and market changes on the organization
• Builds partnerships across the organization. Understands the costs/benefits/risks of pushing cross functional initiatives and makes appropriate tradeoffs.
• Is a positive image and a change agent for others internal and external to the group.
• Pro-Actively communicates effectively and ahead of supplier/customer or team needs.
• Communicates well in group settings with other departments or disciplines. Solicits inputs and involve others in decision making. Actively communicates and questions things to learn and to share ideas for improvements.
• Leads teams and projects while consistently hits project milestones. Creates crisp and clear project plans and develops strong contingency plans as part of project planning process.
• Responsible for decisions that have significant impact to the department and their customers. Follows emerging trends and educates peers in areas of expertise.

Required qualifications:

• Bachelor of Science in Engineering, Chemistry or similar technical field
• 5 or more years of relevant quality engineering experience in medical device manufacturing
• Manufacturing Process Controls experience
• Demonstrated understanding of QSR and ISO standard requirements for Material/Purchasing Controls, Product Realization, Validation and CAPA

Preferred qualifications:

• ASQ Certified Supplier Quality Professional or Certified Quality Engineer
• Problem Solving Subject Matter Expertise; Project Leadership Experience with Packaging, Sterilization Validation, Calibration and Analytical Labs
• Understanding of Quality Agreements
• Ability to work independently, very organized and self-driven
• Medical Device Industry expertise