Job Description

About the Company: North American Rescue provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, 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.

About the Role: 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.

Responsibilities:

• 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.

Qualifications: Bachelor’s 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; or Minimum of 4 years' experience in a federally regulated industry to include Quality Assurance and/or Regulatory Affairs.

Required Skills :

• 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.

Preferred Skills:

• 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.

Pay range and compensation package: This is a full-time position. Days and hours of work are Monday through Friday, 8AM to 5PM. 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.

Equal Opportunity Statement: AAP/EEO Statement: North American Rescue provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, 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.

Job Tags

Similar Jobs