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
You are Pinnacle’s front line. You manage and oversee the document control system and other quality systems, as assigned, to ensure accurate manufacturing of donated human tissue into high-precision product for use as surgical implants. You have direct ownership of the quality assurance systems and their compliant implementation.
Work hours
: Monday – Friday; 8:00 am – 4:30 pm – Onsite position
Work environment:
Office Environment with some interaction within Manufacturing
Location:
North Phoenix, near 19th Avenue and Pinnacle Peak Road
Pay Rate:
$25.00 - $30.00/hour, dependent on experience
What You Will Do
- Train and assist processing or other associates in regard to Quality System process and documentation execution as well as other procedures and systems as assigned or determined.
- Review, process and provide feedback to associates on submissions to the Quality Systems, such as document initiation or changes, document training, or other submissions as assigned.
- Coordinating document control reviews with process owners and customers, as applicable.
- Assist new product development with implementation of controlled documents to ensure timely execution of new products and processes.
- Prioritize, monitor and control documents associated with projects, process improvements, new product development.
- Assist in the approval, release and control of Product related labeling.
- Assist with the quality inspection of returned material authorization (RMA) product and documentation, as needed.
- Collaborate with cross functional Teams to train or participate in business continuity functions, and other tasks as assigned by Leadership.
- Assist in other Quality system functions, as assigned.
What Qualifications You Will Bring
- Associate’s Degree preferred, not required.
- High School diploma required.
- 2 Years of quality experience in a health-related field required.
- 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 in-depth knowledge of processing practices by means of interaction in Review Boards to assist in the processing of quality related documentation.
- 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 daily verbal and written communication with your Leadership to ensure assigned tasks are completed per schedule or Regulatory requirements.
- Your Supervisor. You will maintain daily communication with Quality Leadership providing assignment status and processing observations as determined by your Supervisor.
Where You Will Work
- You will work in an office setting, in a manufacturing facility in North Phoenix, having potential contact with human tissue and bone. You may be required to wear protective clothing including but not limited to hoods, face masks, gloves, boots, and coveralls as determined by the area in which tasks require you to be present.
- Your work is physical in nature. It will require standing for long periods of time, exerting up to 20 pounds of force occasionally and 10 pounds of force frequently to move objects. It also requires repetitive motion with substantial movements of the wrists, hands, and/or fingers.
- You may be required to use equipment including but not limited to desktop computers, and general office equipment.
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.
- Additional benefits such as: Voluntary Life/AD&D, Accident, Critical Illness, Hospital, and Pet Insurance.
- 401(k) Profit Sharing Plan with a 4% company match, eligible first day of the month following 90 days of employment, and 100% Vested from the start of plan.
Paid Time Off:
- (3) weeks paid vacation, prorated based on quarter hired.
- (1) week, 40 hours of paid sick time. Accrual starts at date of hire per pay period. Available to use after 90-days of employment.
- (10) annual paid holidays
Monday - Friday; 8:00 am - 4:30 pm, Onsite position 25.00 To 30.00 (USD) Annually
