Quality Assurance Analyst I

2 weeks ago

Phoenix, Arizona, United States Pinnacle Transplant Techn Full time
Job Overview

Company Background

Pinnacle Transplant Technologies is a leading multi-service tissue bank dedicated to honoring the gift of donation and enhancing patients' quality of life through the meticulous processing and distribution of premium allograft implants. With over a decade of experience, Pinnacle has supported surgeons in improving the lives of countless patients. Our extensive portfolio includes products and solutions across various market segments such as Spine, Sports Medicine, General Orthopedics, Trauma, Dental, and Regenerative Medicine. Pinnacle is fully registered with the Food and Drug Administration (FDA) and accredited by the American Association of Tissue Banks (AATB).

Role Contribution

The Quality Assurance Specialist I serves as the frontline representative for Pinnacle, tasked with maintaining and enhancing the quality management system (QMS). This role involves direct oversight of critical Quality Systems, including Change Control, Customer Complaints, and Returned Materials (RMA). The specialist is responsible for the effective implementation of these quality assurance systems, ensuring that all donated human tissue processed into surgical implants meets the stringent Quality and Safety standards set forth by both internal guidelines and Regulatory Guidance. This position demands exceptional interpersonal and communication skills, along with a solid understanding of quality management principles and methodologies.

Key Responsibilities

  • Act as the subject matter expert (SME) for Change Control, Customer Complaint, and RMA systems.
  • Collect and analyze metrics related to the aforementioned systems as required.
  • Provide insights into system design and support enhancements to the Change Control, Customer Complaint, and RMA systems.
  • Process and review change control requests to ensure adherence to current Quality and Regulatory standards, collaborating with various departments to facilitate successful change management initiatives.
  • Manage customer complaints by investigating issues promptly and ensuring clear communication among all relevant parties.
  • Oversee the RMA process, including documentation, evaluation, quarantine, and disposition of returned allografts.
  • Maintain consistent communication with personnel regarding quality and regulatory matters.
  • Enhance technical skills through ongoing professional development and training.
  • Collaborate with cross-functional teams to provide training and support business continuity efforts.
  • Assist in other departments as needed, gaining cross-training in essential functions.

Qualifications

  • A minimum of 2 years of quality experience in a regulated environment is required.
  • Strong report writing and verbal communication skills are essential.
  • A Bachelor's degree in Technical Communication or a related field is preferred.
  • Familiarity with FDA/ISO regulations related to HCT/Ps and Medical Devices is advantageous.
  • Experience in medical device, pharmaceutical, or HCT/P processing is preferred.

Professional Development

  • Gain expertise in technical investigations related to nonconformances and corrective/preventative actions.
  • Learn to process planned deviations effectively.
  • Acquire knowledge in performing quality reviews of continuous monitoring reports in controlled environments.
  • Develop a comprehensive understanding of industry and Regulatory Quality Best Practices under the guidance of Quality and Regulatory Leadership.

Collaboration

  • Engage regularly with Quality & Regulatory Leadership to collaborate on assigned tasks.
  • Maintain daily communication with your supervisor regarding assignment status and observations.
  • Work effectively in both independent and team settings, ensuring professional communication with all team members.

Work Environment

  • This is a full-time onsite position.
  • The role involves working in an office setting and entering manufacturing and operations environments.
  • Compliance with clean room protocols may be required, including the use of protective clothing.

Benefits

  • Comprehensive medical, dental, and vision insurance.
  • Company-paid short and long-term disability insurance.
  • 401(k) Profit Sharing Plan with a company match.
  • Additional benefits including life insurance and various supplemental insurance options.

Paid Time Off

  • Generous paid time off policy.
  • Accrued paid sick time after a specified period of employment.
  • Annual paid holidays.

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