Senior Supplier Quality Engineer

Position Summary:

​Interfaces with development and supplier engineering to provide materials and components for company product manufacturing. Communicates product specifications to suppliers and assesses supplier’s ability to meet engineering and quality requirements. Evaluates suppliers’ internal functions to assess their overall performance and provides feedback in assessment of their operation. Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.

Position Responsibilities: 

• Responsible in selection of new suppliers and partners for materials and services

• Responsible for leading evaluation and qualification activities of Suppliers providing direct material/service.

• Participate as a core/extended Quality team member of new product development and sustaining teams to assure processes are in place to design and release highly reliable and safe products

• Drives process, quality and product improvements through supplier development activities, risk management, identification and resolution of current and potential issues

• Responsible for updates to purchasing control procedures and processes as needed to stay compliant to quality system requirements and regulations. Provides Quality Assurance expertise and guidance for New Product Development, Manufacturing Operations, Supplier Development, and Product Quality

• Leads purchased material qualification/re-qualification activities such as performance qualification, process validation, first article inspection, measurement gage analysis and capability studies

• Maintain goals and metrics for existing and new products, regularly reporting on the progress to reach departmental objectives

• Leads supplier audits to drive process standardization and continuous improvement

• Identify opportunities for reduced inspection of purchased materials based on risk and quality performance

• Leads and facilitates failure investigations; ensuring mitigations and corrective actions are implemented in a timely manner

• Make recommendations, and drive programs to improve purchased material and supplier performance

• Reviews non-conformance and CAPA reports to identify actions needed to track and improve program health by site or globally.

• Works with strategic partners and suppliers to ensure global awareness and compliance to procedures and specifications

• Ensures effective transfer of Suppliers from development to production activities

• Ability to provide training to other team members to ensure consistency and compliance to processes and procedures.

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Position Requirements: 

• Experience collaborating with cross-functional product development and operational teams

• Strong communication and negotiation skills

• Experience with Quality, Project Management, and Process Engineering methodologies and tools

• Experience with Non-conformance Handling, Failure Investigation (CAPA/SCAR) and Risk Management (FMEA) activities.

• Demonstrated capability in successfully managing and leading change

• Practice identifying, mitigating, and resolving risks

• Ability to work effectively in a fast-paced, dynamic environment with shifting and competing priorities

• Demonstrated experience in Supplier Quality and Management activities such as component qualification, audits, risk assessments.

• Experience with electronic product life cycle (PLM) systems such as Agile, SAP or other PLM systems.

• Practical experience in FDA and ISO regulated environments is a plus

• Experience with statistical analysis packages such as JMP and Minitab is a plus

• Ability to travel domestically and internationally as needed. Estimate 25% of the time.

All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

Preferred Experience/Education/Skills: 

• Experience working in a regulated environment, in-vitro diagnostics preferred

• Requires a minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree in Engineering, Life Sciences, or related field.

• Minimum 3 years specifically working as a Supplier Quality Engineer or in a closely related Supplier Relationship function. Demonstrated track record in component qualification, vendor audits, and supplier risk assessments.

• Deep understanding of failure investigation (CAPA/SCAR), Risk Management (FMEA), First Article Inspection (FAI), and Mistake Proofing.