JT033 - SENIOR SUPPLIER QUALITY ENGINEER

Quality Consulting Group, LLC; Juncos (PR); Hybrid; USD 85,000 - 110,000; Full time

Job summary

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities include ensuring supplier quality, auditing, and supporting GMP compliance; travel to external contract manufacturers and suppliers; and collaboration with

Qualifications

• Bachelor's degree required.
• Minimum of 4 years of relevant experience.
• Ability to work independently under limited supervision.
• Strong communication with internal and external stakeholders.
• Practical knowledge of project management preferred.

Responsibilities

• Ensures that suppliers deliver quality parts, materials, and services.
• Qualifies suppliers and administers a Certified Supplier Program in receiving inspection.
• Monitors parts from acquisition through manufacturing cycle and resolves issues.
• Audits suppliers to GMP and quality standards.
• Evaluates supplier performance and provides feedback.
• Supports Pre-Market Quality Engineering in NPD and with supplier quality teams.
• Guides quality compliance for Supplier Quality across NPD lifecycle.
• Collaborates to develop Product Acceptance Sampling Strategy and supplier lists.
• Defines Receiving Inspection requirements and test method validation.
• Travel to visit external Contract Manufacturers and Suppliers.

Skills

Supplier Quality

Audits

GMP Compliance

NPD Collaboration

Project Management

Communication

Problem Solving

Education

Bachelor's degree

Job description

QUALITY CONSULTING GROUP, a leader inthe pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world‑class manufacturing industry in Puerto Rico & USA.

Responsibilities

• Ensures that suppliers deliver quality parts, materials, and services.
• 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
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation
• Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products
• Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements
• Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products
• Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods
• For this position is key the availability to travel to visit external Contract Manufacturers and Suppliers

Qualifications

• Bachelor's degree required (or, for degrees earned outside the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A))
• Minimum of 4 years of relevant experience
• Works independently under limited supervision to determine and develop approaches to solutions
• Coaches and reviews the work of lower-level specialists; may manage projects and processes
• May be responsible for entire projects or processes within the assigned job area
• Contributes to the completion of work group objectives by building relationships and consensus to reach agreements on assignments
• Demonstrates the ability to solve difficult problems requiring an understanding of multiple issues, job areas, or specialties
• Makes improvements to processes, systems, or products to enhance job area performance
• Provides in-depth analysis and recommendations for process improvements
• Communicates effectively with senior internal and external customers and vendors
• Exchanges information, ideas, issues, and status updates to achieve objectives and influence decision-making
• May provide guidance, coaching, and training to employees within the job area
• May manage projects, including delegating work and reviewing the work products of others
• Possesses advanced knowledge of the job area through a combination of education and relevant experience
• Practical knowledge of project management is preferred
• Available for administrative shift
• Hybrid Type position