Senior Supplier Quality Engineer

Responsibilities

• Assesses 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. Develops corrective action plan where necessary.
• Affords influence across 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).
• Pairs 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.
• Buys 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.
• Proactively communicates effectively and ahead of supplier/customer or team needs.
• Communicates well in group settings with other departments or disciplines. Solicits inputs and involves others in decision making.
• Actively communicates and questions things to learn and to share ideas for improvements.
• Leads teams and projects while consistently hitting 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.

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.