Supplier Quality Engineer

Job DescriptionJob DescriptionSalary:

SUMMARY

Represents the Regulatory Affairs and Quality Assurance department as the Supplier Quality Engineer (SQE) to ensure our suppliers deliver high-quality components, products, and services in compliance with regulatory and quality standards for medical device manufacturing. In this critical role, you will manage supplier quality processes, drive continuous improvement, and collaborate with cross-functional teams, including sourcing, regulatory, manufacturing, and design assurance, to ensure robust supplier performance in a highly regulated environment.

Essential Job Functions

• Ensure supplier compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR, and other applicable international regulations.

• Qualify new suppliers and re-evaluate existing suppliers through risk assessments, pre-assessments, and onsite audits.

• Review and approve supplier-initiated change requests and coordinate internal change requests with suppliers to maintain compliance and quality.

• Lead root cause investigations for supplier-related non-conformances, CAPAs, and SCARs, implementing containment and corrective actions.

• Conduct supplier audits (onsite, remote, and self-assessments) and drive closure of audit findings to ensure continuous improvement.

• Monitor supplier performance through KPIs, scorecards, and trend analysis, recommending process improvements to enhance quality and reliability.

• Collaborate with the Regulatory Affairs team to ensure supplier processes meet sterility and regulatory requirements, without duplicating RA responsibilities.

• Partner with the Design Assurance Engineer to ensure supplier materials meet design specifications and support product validation.

• Manage Design Transfer to contract manufacturer.

• Support incoming inspection processes by defining supplier quality requirements and resolving issues related to incoming materials.

• Assist in managing secondary recalls related to supplier issues, coordinating with cross-functional teams for timely resolution.

• Stay current with evolving regulatory standards (e.g., EU MDR, ISO updates) and ensure suppliers are aligned with new requirements.

• Drive supplier development initiatives, including process optimization and risk mitigation, to support product transfers and new product introductions.

• Maintain accurate and up-to-date supplier records in compliance with quality management systems.

• Performs other duties assigned by supervisor.

Basic Qualifications

• Working knowledge of US FDA and International regulations governing the medical device industry (i.e. QSR, GMP, MDR, and ISO 13485)

• Knowledge of fundamental quality systems principles such as CAPA, Failure Investigation and Management Reviews

• Excellent interpersonal skills including the ability to interface and communicate effectively at all levels, both inside and outside the organization

• Demonstrated ability to plan and manage multiple projects, including the ability to manage the resolution of technical and tactical issues

• Demonstrated ability to understand, apply and analyze statistical controls, process validation and controls, and Inspection and Testing Methods validations

• Must have good communication skills

• Teamwork oriented

QUALIFICATIONS

Education/Experience

• Bachelors degree in engineering, quality assurance, or a related field and a minimum of 2 years' experience in a federally regulated industry to include Quality Assurance and/or Regulatory Affairs; orMinimum of 4 years' experience in a federally regulated industry to include Quality Assurance and/or Regulatory Affairs.

Competencies

• Ability to identify and resolve problems

• Consistently, applies excellent communication skills; both oral and written

• Ability to actively always listen and display professionalism

• Attention to quality and detail

• Solid organizational skills

• Ability to manage multiple priorities

• Ability to work with limited direction and supervision

• Builds and maintains effective working relationships
  

Supervisory Responsibility

This position has no supervisory responsibilities.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to talk or listen. The employee is frequently required to stand, walk; use hands to finger, handle or feel; and reach with hands and arms.

Position Type/Expected Hours of Work

This is a full-time position. Days and hours of work are Monday through Friday, 8:00 a.m. to 5 p.m. Some flexibility in hours is allowed, but the employee must be available during the core work hours and must work 40 hours each week. Occasional evening and weekend work may be required as job duties demand.

Travel

Travel is expected for this position.

DISCLAIMERS

AAP/EEO Statement
North American Rescue provides equal employment opportunity to all individuals regardless of their , , creed, , , , , , , veteran status, or any other characteristic protected by state, federal, or local law. Further, the company takes affirmative action to ensure that applicants are employed, and employees are treated during employment without regard to any of these characteristics. Discrimination of any type will not be tolerated.