Demo

Quality Manager

FORBES REHAB SERVICES INC
Mansfield, OH Full Time
POSTED ON 2/17/2025
AVAILABLE BEFORE 5/16/2025

Benefits :

  • 401(k) matching
  • Paid time off

About Forbes AAC

At Forbes AAC, we are dedicated to providing high-quality communication devices that empower individuals with speech and language challenges. Our mission is driven by a deep commitment to ethical service, and we strive to make a meaningful difference in the lives of those who need our products the most. We are currently seeking a skilled Quality Manager to join our team and help ensure our products meet the highest standards of compliance and quality.

Position Overview

The Quality Manager will be responsible for overseeing the company’s Quality Management System (QMS), ensuring compliance with FDA regulations, and leading the efforts to maintain and improve our processes. This individual will also act as the primary contact for FDA communications, support audits, and implement corrective actions as needed to uphold the quality of our products.

Key Responsibilities

  • Quarterly System Audits
  • Conduct comprehensive audits of the QMS to ensure compliance with 21 CFR Part 820 and other relevant regulations.

  • Prepare detailed audit reports, including findings, corrective actions, and recommendations.
  • Perform follow-up audits to verify the effectiveness of corrective actions.
  • FDA Response Role
  • Serve as the primary point of contact for all FDA communications, including responding to 483 observations, Warning Letters, or other inquiries.

  • Draft, review, and submit FDA correspondence in a timely manner.
  • Provide strategic guidance during FDA inspections to mitigate potential non-conformances.
  • On-Site Support
  • Provide on-site support as needed to address urgent quality issues or assist during inspections.

  • Train staff on compliance, inspection readiness, and quality processes.
  • QMS Improvement
  • Assess the current QMS and recommend improvements to meet evolving regulatory requirements

  • Monitor changes in FDA regulations and advise on necessary adjustments.
  • Support document control, risk management, and CAPA (Corrective and Preventive Actions) processes.
  • Required Qualities

  • Proactive & Detail-Oriented
  • Identifies potential issues before they escalate.

  • Ensures thorough documentation and record-keeping.
  • Strong Communication Skills
  • Communicates effectively with internal teams and regulatory authorities.

  • Translates complex regulatory language into actionable steps for the organization.
  • Availability & Responsiveness
  • Maintains flexibility for urgent or unscheduled matters.

  • Provides prompt support during audits, inspections, and other critical events.
  • Ethical & Objective
  • Acts with integrity and provides impartial assessments during audits.

  • Upholds compliance and quality as top priorities.
  • Expectations for Alignment with Forbes AAC’s Mission

  • Mission-Driven Focus
  • Understands and supports the organization’s mission by ensuring that quality management practices align with delivering high-quality communication devices.

  • Reflects a commitment to ethical standards, mirroring Forbes AAC’s dedication to service and advocacy.
  • Commitment to Quality and Compliance
  • Ensures all products meet or exceed FDA regulations, supporting Forbes AAC's mission to provide reliable communication devices.

  • Advocates for continuous quality improvements to better serve individuals relying on Forbes AAC’s products.
  • Advocacy for Those in Need
  • Focuses on the needs of end-users, ensuring that QMS systems produce devices that assist communication for individuals with disabilities.

  • Promotes accessibility and inclusivity in products and processes.
  • Collaboration and Communication
  • Works collaboratively with Forbes AAC’s team to integrate quality initiatives with the company’s mission.

  • Provides clear, transparent reports and recommendations that reflect the organization’s commitment to integrity and service.
  • Cultural & Ethical Fit
  • Demonstrates behavior and decision-making aligned with Forbes AAC’s values and ethical standards.

  • Exhibits compassion and empathy for the challenges faced by end-users, reinforcing the mission's focus on advocacy and support.
  • Qualifications

  • Bachelor's degree in a relevant field (Engineering, Life Sciences, etc.) or equivalent work experience.
  • Extensive experience with QMS, including audits and compliance with FDA regulations (21 CFR Part 820).
  • Strong understanding of FDA regulations, risk management, CAPA, and document control processes.
  • Excellent written and verbal communication skills.
  • Ability to work independently and as part of a collaborative team.
  • Why Forbes AAC?

    At Forbes AAC, we offer an inclusive, mission-driven workplace where you can make a difference. Join a dedicated team of professionals passionate about delivering life-changing solutions to individuals with communication challenges.

    If you are driven by quality, compliance, and the desire to contribute to a meaningful cause, apply today to be part of our mission!

    How to Apply

    Please submit your resume and cover letter detailing your qualifications and interest in the position to [Insert Application Link or Contact Information].

    Forbes AAC is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

    Flexible work from home options available.

    Salary : $85,000 - $100,000

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