Quality Specialist

Position Summary

The Quality Specialist supports the Quality Management System (QMS) by administering key quality processes to ensure compliance with regulatory standards and customer requirements. This role partners cross-functionally to manage audits, document control, customer complaints, calibration, and continuous improvement activities. The Quality Specialist operates with a high level of ownership and attention to detail to ensure the effectiveness and integrity of the quality system.

Key Responsibilities

Quality Systems Administration

• Administer and maintain QMS processes in compliance with internal procedures and regulatory standards.
• Maintain accurate and complete quality records from initiation through closure in accordance with cGDP requirements.

Document Management

• Manage document control processes, including document review, approval, revision, and release.

Customer Complaint Management

• Manage the customer complaint process from receipt through closure, including: 
  • Intake and tracking of complaints
  • Coordination with Customer Service for communication
  • Product evaluation and disposition
  • Risk assessment and investigation
  • Development of customer responses and follow-up actions

Audit & Compliance

• Execute internal audits independently or as part of an audit team.
• Assist in developing and maintaining the internal audit schedule.
• Track audit completion, manage corrective actions, and ensure timely closure.
• Support external regulatory and customer audits as needed.
• Perform periodic reviews of applicable regulatory standards and maintain current documentation.

Measurement & Calibration

• Oversee the calibration program for laboratory and production measurement equipment, ensuring accuracy and compliance with required standards.

Supplier & External Services Coordination

• Coordinate pest management activities with external vendors, including scheduling, reviewing service reports, and implementing recommendations.

Reporting & Communication

• Prepare quality metrics, reports, charts, and summaries to support decision-making and compliance tracking.
• Collaborate effectively with internal teams and external partners to ensure alignment with quality requirements.
• Escalate quality or compliance risks to the Quality Manager as appropriate.

Additional Responsibilities

• Support customer and internal requests for product or system-related information.
• Perform other duties as assigned to support the Quality function.

Qualifications

Education & Experience

• Associate or bachelor’s degree in a related field preferred.
• Experience working within a Quality Management System (QMS), preferably in an ISO 9001, or ISO 13485 certified environment, strongly preferred.

 Skills & Competencies

• Strong organizational skills with the ability to manage multiple priorities and meet deadlines.
• High attention to detail with strong documentation and follow-up skills.
• Proficiency in Microsoft Office applications.
• Strong verbal and written communication skills.
• Ability to work independently and collaboratively in a team environment.
• Communicating professionally with internal teams, customers, and external vendors to resolve quality issues.
• Ability to maintain confidentiality and handle sensitive information appropriately.
• Ability to develop and apply detailed product knowledge to evaluate nonconformances, coordinate disposition decisions, and ensure required approvals and records are completed.

Work Environment 

• Combination of office and manufacturing floor environment.
• May require use of personal protective equipment (PPE) when entering production areas.

Equal Opportunity Statement

Transcendia is an equal opportunity employer and will consider all candidates for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.