Supplier Qual Engineer I

Echo-Consulting-Group; Villalba (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

ECHO Consulting Group in Villalba, Puerto Rico, is seeking an entry-level contributor to advance supplier quality initiatives and new technologies in GMP environments. You will work with cross-functional teams to ensure ongoing compliance and quality improvements.

The role emphasizes auditing, supplier qualification, and quality engineering support for NPD, with a Bachelor’s degree in Engineering required and on-site 1st shift in Villalba.

Qualifications

• Bachelor's degree in Engineering required.
• GMP knowledge and manufacturing processes preferred.
• Experience in supplier quality or QA activities is a plus.
• Ability to work with cross-functional teams.

Responsibilities

• Ensure suppliers deliver quality parts, materials, and services.
• Qualify suppliers according to company standards and administer supplier quality programs.
• Monitor parts from acquisition through the manufacturing cycle and resolve supplier-related issues.
• Develop and prioritize an auditing schedule to ensure GMP and quality standards.
• Evaluate suppliers' performance and provide feedback on operations.
• Provide Pre-Market Quality Engineering support for NPD and collaborate with engineering teams.
• Define receiving inspection requirements and validate test methods.

Skills

Autonomy

Organizational Impact

Innovation and Complexity

Communication and Influence

Education

Bachelor's degree in Engineering

Job description

ECHO Consulting Group is a leader in providing solutions for the pharmaceutical, biotechnology, medical devices, and food industries. ECHO Consulting Group delivers high-quality solutions in CQV, quality management, regulatory compliance, manufacturing support, and project management. We are committed to offering exciting career opportunities in a workplace that values trust, respect, teamwork, creative talent, enthusiasm, and diligence. We are looking for talented professionals who are passionate about quality, collaboration, and delivering results. We believe great talent deserves great rewards. That’s why we offer a competitive compensation package and professional development.

Summary of Role:

An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies - from design to implementation - while adhering to policies, using specialized knowledge and skills.

Responsibilities:

• Responsibilities may include the following and other duties may be assigned.

• 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.

• Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include: 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.

Shift: 1st Shift

Location: Villalba, PR

Education: Bachelors degree in Engineering

Preferred Qualifications:

• Knowledge of GMPs manufacturing

• Validation of equipment and process

• Risk analysis

Skills:

• Autonomy: Entry-level individual contributor on a project or work team. Works with close supervision.

• Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities.

• Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex.Makes minor changes in systems and processes to solve problems.

• Communication and Influence: Communicates primarily with internal contacts within immediate group.Contacts others to gather, confirm and convey information.

Equal Employment Opportunity

ECHO Consulting Group, Inc. is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law.

We assure you that your opportunity for employment with ECHO Consulting Group, Inc. depends solely on your qualifications.