Sr Supplier Qual Engineer

Medtronic plc; Villalba (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Medtronic plc is seeking a Senior Supplier Quality Engineer to lead quality activities across the New Product Development lifecycle, ensuring suppliers meet GMP, regulatory, and performance requirements. You will partner with external suppliers and internal teams to establish supplier controls, drive product quality, and support qualification and launches of new products.

The role requires extensive experience in supplier quality, quality engineering, and working within regulated environments,

Qualifications

• Bachelor's degree required with 4+ years in supplier quality, quality engineering, manufacturing quality, or medical device experience; or advanced degree with fewer years.
• Experience qualifying suppliers, processes, materials, or components.
• Experience applying quality tools such as root cause analysis, CAPA, risk management, or statistical analysis.
• Knowledge of supplier quality systems, auditing practices, and quality control methodologies.
• Experience in regulated industries and quality management systems.

Responsibilities

• Lead supplier quality activities for New Product Development from concept to launch.
• Qualify suppliers, processes, materials, and components per quality system and regulations.
• Support supplier process validation, sampling, and control plan development.
• Collaborate with suppliers and cross-functional teams to establish controls and quality plans.
• Develop sampling strategies and Supplier Owned Quality programs for new products.
• Define receiving inspection requirements and validate internal test methods.
• Investigate supplier-related quality issues and drive CAPA to resolution.
• Conduct supplier audits to ensure GMP and regulatory compliance.
• Monitor supplier performance metrics and drive continuous improvement.

Skills

Root cause analysis

CAPA

Risk management

Statistical analysis

Auditing practices

Quality control methodologies

Education

Bachelor's degree in engineering or science

Job description

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first - developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

The Senior Supplier Quality Engineer is responsible for providing quality engineering leadership throughout the new product development lifecycle, ensuring that suppliers consistently meet Medtronic quality, regulatory, and performance requirements. This role works collaboratively with external suppliers and internal stakeholders to establish supplier controls, drive product quality, resolve supplier-related issues, and support the successful qualification and launch of new products.

Primary Responsibilities

• Lead supplier quality activities supporting New Product Development (NPD) programs from concept through commercialization.
• Qualify suppliers, processes, materials, and components in accordance with Medtronic quality system and regulatory requirements.
• Support supplier process validation, product acceptance sampling, and control plan development.
• Partner with suppliers and cross-functional teams to establish robust supplier controls, risk mitigation strategies, and quality plans.
• Develop and implement product acceptance sampling strategies, control plans, and Supplier Owned Quality programs for new products.
• Define receiving inspection requirements and support validation of internal test methods used for supplier quality verification.
• Investigate supplier-related quality issues, identify root causes, and drive corrective and preventive actions to resolution.
• Conduct supplier audits and assessments to ensure compliance with Good Manufacturing Practices (GMP), quality standards, and applicable regulations.
• Monitor supplier performance metrics and drive continuous improvement initiatives to improve quality, reliability, and operational effectiveness.

Required Qualifications

• Bachelor's degree and 4+ years of supplier quality, quality engineering, manufacturing quality, or medical device experience OR Master's degree and 2+ years of related experience OR PhD.
• Experience qualifying suppliers, manufacturing processes, materials, or components.
• Experience applying quality tools such as root cause analysis, Corrective and Preventive Action (CAPA), risk management, or statistical analysis.
• Knowledge of supplier quality systems, auditing practices, and quality control methodologies.
• Experience working within regulated industries and quality management systems.

Preferred Qualifications

• Experience supporting New Product Development (NPD) and product commercialization activities.
• Knowledge of FDA regulations, ISO 13485, and Good Manufacturing Practices (GMP).
• ASQ Certified Quality Engineer (CQE), Certified Supplier Quality Professional (CSQP), or equivalent quality certification.
• Experience collaborating with global suppliers and cross-functional engineering teams.
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

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