Quality Assurance Specialist II

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 II is responsible for sustaining and improving the quality management system (QMS) through direct operation and oversight of the following Quality Systems: nonconformance, corrective/preventative action and planned deviations. The Quality Assurance Specialist II has direct ownership of the specified quality assurance systems and their compliant implementation. The Quality Assurance Specialist II 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 strong knowledge of quality management principles, practices, and methodologies.

• The Quality Assurance Specialist II is an onsite position located in North Phoenix
• Annual Salary for this position is dependent upon experience, ranging from $67,000 - $81,000

What You Will Do

• Serves as the subject matter expert (SME) for technical writing and nonconformance, corrective and preventative action (CAPA) and planned deviation systems.
• Gathers information and analyzes metrics related to nonconformance, corrective/preventative actions, and planned deviations systems, as requested. Generates charts, graphs, and presentations based on data collection.
• Provides input into system design and supports process improvements to the nonconformance, corrective/preventative actions and planned deviations systems as requested.
• Authors and evaluates technical investigations across nonconformance, deviation, and corrective/preventative action assignments. Determines investigatory outcomes pertaining to tissue disposition, event root cause, identification of corrective / preventative actions, and final determination of effectiveness. Partners with the Medical Director when a nonconformance is discovered to be affect tissue safety. Submits final reports for approval and closure.
• Reviews and deploys planned deviation proposals with interdepartmental leadership for compliant implementation with Quality and Regulatory requirements, including initial assessment and closure reports.
• Provides training on Quality Systems methods and requirements for inter and intra-departmental associates, to develop employees’ abilities to support the organization’s quality program, meeting, or exceeding goals.
• Applies departmental SOPs and participates in the development and authorship of departmental SOPs, as appropriate.
• Maintains open, regular communication with appropriate personnel concerning quality and/or regulatory issues.
• Maintains and advance technical skills through professional education and training to advance the effectiveness of Quality Systems.
• Cross-trains in critical functions and assist in other departments as assigned by supervisor.

What Qualifications You Will Bring

• Proficient in technical and report writing, strong verbal and presentation skills.
• 5 Years of quality assurance experience in a regulated field is required.
• 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 in leadership to effectively assist in the oversight of all quality assurance functions.
• Develop decision making skills to support continuous improvement of the quality assurance systems.
• Develop skills and knowledge in supporting customer complaint investigations, returned material (RMA) and change control systems.
• Develop skills and knowledge in supporting the document control system.

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 position (40 hours or more). The Quality Assurance Specialist II position is eligible for remote work or hybrid remote work.
• You will work in an office setting and may enter the manufacturing and operations environments, if onsite in Phoenix. You will be required to use equipment including but not limited to desktop computers, and general office equipment.
• The Quality Systems Specialist II may work in a clean room environment where protective clothing such as hoods, face masks, gloves, boots, and coveralls are required, if onsite in Phoenix.

Benefits/Total Rewards

• 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:

• (4) weeks paid vacation, given at time of hire
• (1)week paid sick time, accrued per pay period beginning after 90-days of employment
• (10) annual paid holidays