Quality Assurance Specialist I

About Us

Pinnacle Transplant Technologies is a multi-service tissue bank committed to honoring the gift of donation and improving patient’s quality of life through the processing and distribution of high-quality allograft implants. For over a decade, Pinnacle has helped surgeons improve the lives of thousands of patients. We offer a comprehensive portfolio of products and solutions across multiple market segments, including Spine, Sports Medicine, General Orthopedics, Trauma, Dental, and Regenerative Medicine. Pinnacle is registered with the Food and Drug Administration (FDA) and accredited by the American Association of Tissue Banks (AATB).

How You Contribute to Pinnacle Transplant’s Success

The Quality Assurance Specialist I is Pinnacle’s front line; they are responsible for sustaining and improving the quality management system (QMS) through direct operation and oversight of the following Quality Systems: Change Control, Customer Complaints and Returned Materials (RMA). The Quality Assurance Specialist I has direct ownership of the specified quality assurance systems and their compliant implementation. The Quality Assurance Specialist I ensures donated human tissue, which is processed into high-precision products for use as surgical implants, meets the appropriate Quality and Safety requirements defined internally and by Regulatory Guidance. This role requires excellent interpersonal and communications skills, as well as knowledge of quality management principles, practices, and methodologies.

The Quality Assurance Specialist I is located onsite in North Phoenix

Defendant upon your experience you hourly pay rate rage is $23.72 - $32.33

What You Will Do

• Serve as the subject matter expert (SME) for the Change Control, Customer Complaint and RMA systems.
• Gathers information and analyzes metrics related to Change Control, Customer Complaint and RMA systems, as requested.
• Provides input into system design and supports process improvements to the Change Control, Customer Complaint and RMA systems as requested.
• Processes, reviews, and monitors submitted change control requests to ensure compliance with current Quality and Regulatory requirements. Interfaces with interdepartmental stakeholders to coordinate change management activities, ensuring the success of change management initiatives.
• Receives, performs, and oversees responses to customer complaints and investigates to solve issues promptly. Acts as an intermediary to provide clear communication between all internal and external parties regarding any outstanding issues. Performs root cause analysis, trending, tissue disposition; and submitting final reports to the Quality Systems Manager for final approval and closure.
• Manages the returned materials authorization (RMAs) process through the documentation, evaluation, quarantine and disposition of returned allografts.
• Maintains open, regular communication with appropriate personnel concerning quality and/or regulatory issues.
• Maintains and advances technical skills through professional education and training to advance the effectiveness of Quality Systems.
• Collaborates with cross functional Teams to train or participate in business continuity functions, and other tasks as assigned by Leadership.
• Cross-trains in critical functions and assists in other departments as assigned by supervisor.

What Qualifications You Will Bring

• 2 Years of quality experience in a regulated field is required.
• Proficient in report writing, strong verbal and presentation skills.
• Bachelor’s degree in Technical Communication or related degree is preferred.
• Knowledge of FDA/ISO regulations associated with processing and manufacturing of HCT/Ps and Medical Devices and/or Biologics is preferred.
• Experience in medical device, pharmaceutical, or HCT/P processing or blood banking is preferred.

How You Will Grow

• Develop skills and knowledge in technical investigations related to nonconformances, corrective/preventative action.
• Develop skills and knowledge in processing planned deviations.
• Develop skills and knowledge in performing the Quality review of continuous monitoring reports related to temperature, humidity, pressure, etc. in controlled environments.
• Develop in-depth knowledge of industry and Regulatory Quality Best Practices and Process Monitoring under the guidance of Quality and Regulatory Leadership, implementing these through completion of assigned tasks and investigations.

Who You Will Partner With

• Quality & Regulatory Leadership. You will have regular verbal and written communication with applicable Quality and Regulatory Leadership to collaborate on assigned tasks.
• Your Supervisor. You will maintain daily communication with Quality Leadership providing assignment status and processing observations as determined by your Supervisor.
• Your Team. Regularly work in independent and team settings maintaining professional communication with all PTT team members.

Where You Will Work

• Full Time onsite position (40 hours or more) based in Arizona.
• You will work in an office setting and regularly enter the manufacturing and operations environments. You will be required to use equipment including but not limited to desktop computers, and general office equipment.
• The Quality Assurance Specialist I may work in a clean room environment where protective clothing such as hoods, face masks, gloves, boots, and coveralls are required.

Benefits: Company benefits package includes:

• Comprehensive medical, dental, and vision insurance, eligible first day of the month following your start date
• Company-Paid Short and Long-term Disability Insurance
• Company-Paid Identity Theft Protection
• Company-Paid Life Insurance Policy of $50,000
• 401(k) Profit Sharing Plan with a 4% company match, eligible first day of the month following 90 days of employment.
• Additional benefits such as: Additional Life/AD&D, Accident, Critical Illness, and Pet Insurance

Paid Time Off:

• Paid time off given at the increments below:
  • January 1st 40 hours
  • April 1st 30 hours
  • July 1st 30 hours
  • October 1st 20 hours
• (1) week paid sick time, accrued per pay period beginning after 90-days of employment
• (10) annual paid holidays