Quality Assurance Specialist I

4 weeks ago

Phoenix, United States Pinnacle Transplant Techn Full time
Job DescriptionJob Description

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. The work hours are typically Monday – Friday, 8 hours per day somewhere in between the times of 7:30 am to 5:00 pm.

Dependent upon experience the hourly pay rate rage is $28.00 - $33.00.

What You Will Do

  • Serve as the subject matter expert (SME) for the Change Control, Customer Complaint and RMA systems.
  • Gather information and analyze metrics related to Change Control, Customer Complaint and RMA systems, as requested.
  • Provide input into system design and support process improvements to the Change Control, Customer Complaint and RMA systems as requested.
  • Process, review, and monitor submitted change control requests to ensure compliance with current Quality and Regulatory requirements. Interface with interdepartmental stakeholders to coordinate change management activities, ensuring the success of change management initiatives.
  • Receive, perform, and oversee responses to customer complaints and investigate to solve issues promptly. Act as an intermediary to provide clear communication between all internal and external parties regarding any outstanding issues. Perform root cause analysis, trending, tissue disposition; and submitting of final reports to the Quality Systems Manager for final approval and closure.
  • Manage the returned materials authorization (RMAs) process through the documentation, evaluation, quarantine and disposition of returned allografts.
  • Maintain open, regular communication with appropriate personnel concerning quality and/or regulatory issues.
  • Maintain and advance technical skills through professional education and training to advance the effectiveness of Quality Systems.
  • Collaborate with cross functional Teams to train or participate in business continuity functions, and other tasks as assigned by Leadership.
  • Crosstrain in critical functions and assist 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, Hospital Indemnity, 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.

  • Quality Assurance Specialist

    1 week ago

    Phoenix, Arizona, United States JCO Workforce Solutions Full time

    Quality Assurance Specialist Job DescriptionJob Title: Quality Assurance SpecialistReports To: Quality Assurance ManagerSummary:We are currently seeking experienced Quality Assurance Specialists to ensure the highest standards of quality and precision across our product lines. If you're detail-oriented, skilled in dimensional tolerance inspection, and...

  • Quality Assurance Specialist

    2 weeks ago

    Phoenix, Arizona, United States JCO Workforce Solutions Full time

    Quality Assurance Specialist Job DescriptionJob Title: Quality Assurance SpecialistReports To: Quality Assurance ManagerOverview:JCO Workforce Solutions is in search of skilled Quality Assurance Specialists who are committed to maintaining exceptional quality and accuracy throughout our production processes. If you possess a keen eye for detail and expertise...

  • Quality Assurance Specialist

    2 weeks ago

    Phoenix, Arizona, United States COIL TEC OF ARIZONA INC Full time

    Job OverviewWe are looking for a dedicated Quality Assurance Specialist to oversee the quality standards of our products. The specialist will conduct routine inspections and evaluations to ensure that all manufacturing processes meet the required specifications and prevent any defects.Key Responsibilities:Conduct comprehensive assessments of raw materials...

  • Quality Assurance Analyst I

    2 weeks ago

    Phoenix, Arizona, United States Pinnacle Transplant Techn Full time

    Job OverviewCompany BackgroundPinnacle 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...

  • Quality Assurance Specialist

    1 day ago

    Phoenix, Arizona, United States Talnt Full time

    Job Summary:We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team at Talnt. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and safety of our products.Key Responsibilities:Implement and Enforce Quality Standards: Develop and implement quality control procedures to ensure...

  • Quality Assurance Specialist

    5 days ago

    Phoenix, Arizona, United States Atkore Full time

    Job Summary:We are seeking a highly skilled Quality Assurance Specialist to join our team at Atkore. As a Quality Assurance Specialist, you will be responsible for ensuring the quality and compliance of our products.Key Responsibilities:Interpret and apply manufacturing drawings and specifications to ensure product compliance.Conduct product inspections...

  • Quality Assurance Specialist

    2 weeks ago

    Phoenix, Arizona, United States Insight Global Full time

    Position Overview: We are seeking a dedicated Quality Assurance Specialist to join our team at Insight Global. This role is essential in ensuring the highest standards of quality in our manufacturing processes.Compensation: Competitive salary range based on experience.Work Schedule: This position requires availability for a weekend shift, with opportunities...

  • Quality Assurance Specialist

    3 days ago

    Phoenix, Arizona, United States JCO Workforce Solutions Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at JCO Workforce Solutions. As a Quality Assurance Specialist, you will be responsible for ensuring the highest quality standards in our aerospace manufacturing operations.Key ResponsibilitiesCollaborate with Operations Team: Work closely with the operations team to...

  • Quality Assurance Specialist

    2 weeks ago

    Phoenix, Arizona, United States Insight Global Full time

    Position Overview: We are seeking a dedicated Quality Assurance Specialist to join our team. This role is essential in ensuring the highest standards of quality in our manufacturing processes.Compensation: Competitive salary range based on experience.Work Schedule: This position requires availability for a weekend shift, with opportunities for additional...

  • Quality Assurance Specialist

    1 week ago

    Phoenix, Arizona, United States MTM Full time

    MTM is seeking a Quality Assurance Specialist. The Quality Assurance Specialist plays a crucial role in overseeing customer feedback in alignment with industry standards and MTM's Quality Management protocols. Responsibilities include: Documenting, reviewing, and investigating all customer feedback. Inputting complaints received through various...

  • Quality Assurance Specialist

    2 weeks ago

    Phoenix, Arizona, United States MTM Full time

    MTM is seeking a Quality Assurance Specialist for an onsite role. The Quality Assurance Specialist plays a crucial role in overseeing and addressing complaints in line with regulatory requirements and MTM's Quality Management protocols. Key Responsibilities: Document, assess, investigate, and follow up on all complaints. Input complaints received...

  • Quality Assurance Specialist III

    11 hours ago

    Phoenix, Arizona, United States Raytheon Technologies Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist III to join our team at Raytheon Technologies. As a Quality Assurance Specialist III, you will be responsible for ensuring the quality of our products and services, and for implementing processes and procedures to improve our quality management system.Key ResponsibilitiesConduct quality...

  • Quality Assurance Specialist

    2 weeks ago

    Phoenix, Arizona, United States MTM Full time

    MTM is seeking a Quality Assurance Specialist for an onsite role. The Quality Assurance Specialist plays a crucial role in overseeing complaints in line with AHCCCS (Arizona Health Care Cost Containment System) standards and MTM's Quality Management protocols. Key Responsibilities: Accurately document, assess, investigate, and track all AHCCCS...

  • Quality Assurance Specialist

    2 weeks ago

    Phoenix, Arizona, United States Spherion Staffing and RecruitingCleanpart Full time

    Job OverviewWe are seeking a dedicated and skilled Quality Assurance Specialist to join our innovative team. This role is essential in maintaining the highest standards of quality within our production processes.As a Quality Assurance Specialist, you will play a crucial role in ensuring that our products meet stringent quality requirements and operational...

  • Quality Assurance Specialist

    5 days ago

    Phoenix, Arizona, United States Nesco Resource Full time

    **Job Summary**Nesco Resource is seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and safety of our products.**Key Responsibilities:**Assist Operations in maintaining Good Manufacturing Practices (GMP) and Standard Operating...

  • Quality Assurance Specialist

    5 days ago

    Phoenix, Arizona, United States Katalyst HealthCares & Life Sciences Full time

    Job SummaryKatalyst HealthCares & Life Sciences is seeking a highly skilled Quality Engineering Consultant to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the company's medical devices meet all regulatory requirements and quality standards.Key ResponsibilitiesQuality Control Planning: Develop and implement quality...

  • Senior Quality Assurance Automation Specialist

    2 weeks ago

    Phoenix, Arizona, United States mPulse Mobile Full time

    Position Overview: mPulse Mobile is seeking a Senior Quality Assurance Automation Specialist to collaborate with internal teams in defining system requirements. This pivotal role within the engineering department involves contributing to the formulation and execution of the company's quality assurance strategy. The Senior QA Automation Specialist will engage...

  • Quality Assurance Systems Specialist

    2 weeks ago

    Phoenix, Arizona, United States TSMC Full time

    Quality Assurance Systems Specialist At TSMC, we are at the forefront of innovation, transforming groundbreaking ideas into products that make a significant impact on lives worldwide. If you share our commitment to excellence, you will find a rewarding opportunity with us. We are seeking a Quality Assurance Systems Specialist to join our advanced...

  • Quality Assurance Specialist

    1 week ago

    Phoenix, Arizona, United States Select Source International Full time

    Job OverviewPosition: Quality Assurance SpecialistContract Duration: 6+ MonthsKey Responsibilities:Examine production data and inspection reports to identify patterns and suggest improvements.Compile and present quarterly performance metrics to upper management.Develop, assess, and refine quality assurance protocols and methodologies.Ensure adherence to...

  • Revenue Quality Assurance Specialist

    3 days ago

    Phoenix, Arizona, United States Sonora Quest Full time

    Job SummaryJob Title: Revenue Quality Assurance SpecialistJob Summary: We are seeking a highly skilled Revenue Quality Assurance Specialist to join our team at Sonora Quest. As a key member of our Revenue Department, you will be responsible for identifying and evaluating quality and productivity, training new employees, and ensuring compliance with all...