Job Summary
We are seeking an enthusiastic and detail-oriented Trainee Quality Manager with prior medical device / ISO 13485 audit experience to join our energetic team. This early-level position offers a valuable opportunity to build essential quality management skills at an orthobiologics medical device distributor. In this role, you will help implement and maintain quality systems, assist with operations, and ensure compliance with industry standards and regulations. As a paid opportunity, it supports your growth in quality assurance, control, and management, paving the way for a successful career in quality leadership.

Responsibilities

The trainee will develop foundational skills through hands-on operational involvement, focusing on these key areas for the first 9 months:

• Operations: Learning quality integration within day-to-day warehouse and supply chain workflows.
• Compliance: Implementing procedures aligned with Operational Mastery: Actively participating in day-to-day warehouse and supply chain activities to understand how quality standards integrate with operational workflows.
• Regulatory Compliance: Learning and implementing operational procedures that ensure strict adherence to Good Manufacturing Practice (GMP) and ISO 13485 standards for medical device quality management systems.
• Process Implementation: Translating quality guidelines into actionable operational protocols, ensuring all documentation and physical processes meet institutional excellence and regulatory requirements.
• Implementation: Converting quality guidelines into actionable operational protocols and documentation.

Future Career Path

The professional development track for the Trainee Quality Manager is designed for rapid growth. Candidates will begin with 9 months of immersive, hands-on experience within operational departments to master and apply procedures aligned with ISO 13485 and GMP requirements. Upon meeting key performance milestones, the trainee is anticipated to transition into a full Quality Manager position by the 12-month mark.

Qualifications

• First degree in a quality-related discipline.
• Medical Device and ISO 13485 experience required.
• Highly precise, methodical, and detail-oriented approach to work.
• Strong statistical awareness and analytical capabilities.
• Bright, hands-on self-starter who takes personal responsibility for the quality of their deliverables.
• Excellent communicator and proactive team player.

Experience

This is an entry-level position; prior professional experience is not required.

Mentors & Support Structure

To facilitate growth, the trainee will be supported by a diverse mentoring team, including:

• Fractional Quality Manager
• Regulatory Consultant.
• Chief Scientific Office.

Professional Training Opportunities

Structured training is provided in the following core areas:

• Certified Quality Auditor (CQA) training.
• Advanced Good Manufacturing Practice (GMP) standards.
• ISO 13485 implementation and internal auditing protocols.

Review Schedule

Progress will be evaluated via Quarterly Reviews, which will focus on setting specific performance and development metrics for each subsequent three-month period.

Please note: As a small distributor, we are not able to offer health insurance

Pay: $30.00 - $37.00 per hour

Benefits:

• Paid time off
• Professional development assistance

Application Question(s):

• What interests you about this position? How does your background fit the Trainee Quality Manager role?
• What is your expected salary range?
• Do you have experience with ISO 13485 for Medical Devices? Please elaborate on your experience.
• Please describe your direct experience preparing for and participating in an ISO audit.

Experience:

• Quality Assurance: 1 year (Preferred)
• Medical Device: 1 year (Required)

Language:

• English (Required)

Location:

• Brooklyn, NY 11201 (Preferred)

Ability to Relocate:

• Brooklyn, NY 11201: Relocate before starting work (Required)

Work Location: In person