- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- (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
-
Delivery Assurance Specialist
6 days ago
Plaxonic Technologies Inc. Phoenix, United States**Role - Delivery Assurance Field Representative** · **Location - Pheonix, AZ (Onsite)** · **Duration - Fulltime** · **Key Skills**: · **Supplier Delivery Assurance,** · **Project Management,** · **Supply Chain,** · **Aftermarket Programs** · Pay: $80, $85,000.00 per year · **Ben ...
-
Quality Assurance Specialist Ii
4 days ago
Pinnacle Transplant Techn Phoenix, United States**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 sur ...
-
Quality Assurance Produce Specialist
3 days ago
Shamrock Foods Company Phoenix, United StatesPay: Starting at $27/HR (D.O.E) · Schedule: 5:30 AM-3:00 PM · Full-Time: Saturday's & Tuesday's Off · A Shamrock Foods Quality Assurance Specialist is the voice of the customer and should always have the customers best interest in mind. The role encompasses but is not limited to, ...
-
Quality Assurance Specialist Phoenix, Az
2 weeks ago
Avenue5 Residential, LLC Phoenix, United States**The pay for this position is $80,000 per year.** · **Avenue5 is growing, and we are in search of a quality assurance specialist to join our dynamic team of Fivers** · **Summary of Responsibilities** · The quality assurance specialist is responsible for observing, measuring, and ...
-
Financial Aid Quality Assurance Specialist
1 week ago
Arizona College of Nursing Phoenix, United StatesWhy You Should Work With Us: · **Arizona College of Nursing is seeking a Quality Assurance Specialist to join our growing Financial Aid Team** · **This position offers a Monday - Friday hybrid schedule with 2 days in-office (I-17/Dunlap in North Phoenix) and 3 days working from h ...
-
V Digital Services Phoenix, United StatesAre you the type of person who cannot walk by a crooked picture without adjusting it? · Do you prefer to have your drink perfectly centered on a coaster or napkin? · Are you good at those "what's different in these two pictures" types of puzzles? · As a Quality Assurance Speciali ...
-
Quality Assurance Specialist
2 weeks ago
Counseling4Kids Glendale, United States**Job Title**:Quality Assurance Specialist I · **Department**:Compliance & Quality Assurance · **Reports To**:Director of Compliance & Quality Assurance · **Hours**:Full Time, 40 hours (M-F; Occasional evening and weekend work required) · **FLSA Status**:Non-Exempt, · **Employmen ...
-
Quality Assurance Specialist
1 week ago
United Dairymen of Arizona Tempe, United States**ABOUT UDA**: · UDA is a local, family-owned, dairy cooperative committed to serve the needs of our members, community, and customers by providing high quality milk and dairy products. As the only milk marketing co-op in the state, UDA oversees the production, processing, and ma ...
-
Quality Assurance Specialist
1 week ago
UDA Tempe, United States**ABOUT UDA**: · UDA is a local, family-owned, dairy cooperative committed to serve the needs of our members, community, and customers by providing high quality milk and dairy products. As the only milk marketing co-op in the state, UDA oversees the production, processing, and ma ...
-
Quality Assurance Specialist
3 weeks ago
DSV Mesa, United StatesIf you are a current DSV employee and interested in a position in another country,please contact your Human Resource representative to discuss the process and requirements of applying. · - Job area: Quality**DSV - Global transport and logistics** · In 1976, ten independent haulie ...
-
Quality Assurance Specialist
6 days ago
Avenue5 Residential Phoenix, United StatesThe pay for this position is $80,000 per year. · Avenue5 is growing, and we are in search of a quality assurance specialist to join our dynamic team of Fivers · Summary of Responsibilities · The quality assurance specialist is responsible for observing, measuring, and documenti ...
-
Quality Assurance Specialist
1 week ago
Avenue5 Residential Phoenix, United StatesThe pay for this position is $80,000 per year. Avenue5 is growing, and we are in search of a quality assurance specialist to join our dynamic team of FiversSummary of ResponsibilitiesThe quality assurance specialist is responsible for observing, measuring, and documenting all are ...
-
quality assurance specialist
1 week ago
BrightSpring Health Services Phoenix, United States· QUALITY ASSURANCE SPECIALIST - DDD GROUP HOMES · Job Locations · US-AZ-PHOENIX · ID · Line of Business · ResCare Community Living · Position Type · Full-Time · Pay Min · USD $17.00/Hr. · Pay Max · USD $20.00/Hr. · Our Company · ResCare Community Living · Overview · Our Qualit ...
-
Specialist - Quality Assurance/Management
4 days ago
Redwood Ventures Paradise Valley, AZ, United States Freelance**YOU + US = JOB** · - **For our client Carl Zeiss IMT GmbH in 73457 Essingen, we are looking for a long-term Quality Assurance/Management Specialist (m/f/d).** · **Your responsibilities** · - Perform calibrations of high-quality reference standards on shape and 3D coordinate mea ...
-
Quality Assurance Specialist
1 week ago
Caris Life Sciences Phoenix, United StatesJob Location Phoenix - CC1 - Phoenix, AZ Education Level Undisclosed * Meets all deliverables and goals set by department. · Meets all regulatory agency requirements as they pertain to job function. · Maintains exceptional quality standards for all data input into all company d ...
-
Quality Assurance Specialist
1 week ago
Honeywell Phoenix, United StatesLaunch innovations in nearly every commercial and defense aircraft platform · Provide Quality Control Inspection support for Honeywell [insert business group or function] while partnering with manufacturing teams and leaders. You will ensure that quality in being maintained in a ...
-
quality assurance specialist
1 week ago
BrightSpring Health Services Phoenix, United StatesOur Company · ResCare Community Living · Overview · Our Quality, Risk and Compliance teams focus on maintaining compliance and auditing to mitigate risk for our operations. This keeps the company in compliance with State, Federal and overall company requiremens, but most impor ...
-
Quality Assurance Specialist I
1 week ago
Pinnacle Transplant Techn Phoenix, United StatesJob Description · Job DescriptionAbout 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 de ...
-
Processing Quality Assurance Specialist
1 week ago
JA Solar AZ LLC Phoenix, United StatesThe Processing Quality Assurance Specialist is responsible for the process control; product production, including raw material launch, product inspection, acceptance and quality status tracking, quality deficiencies, and ensuring the accuracy and efficiency of the processing oper ...
-
Apex Ventures Surprise, AZ, United States Freelance**Join our team in Surprise, AZ as:** · **Quality Assurance Specialist in Final Inspection (m/f/d)** · **Your responsibilities as a Quality Assurance Specialist in Final Inspection (m/f/d):** · - Reviewing order documents for completeness in terms of documentation and execution o ...
Quality Assurance Specialist II - Phoenix, United States - Pinnacle Transplant Techn
Description
Job Description
Job DescriptionAbout 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.
What You Will Do
What Qualifications You Will Bring
How You Will Grow
Who You Will Partner With
Where You Will Work
Benefits/Total Rewards
Paid Time Off:
Quality Assurance Specialist II professionals in Phoenix
-
Eustacio Martinez
General Labor, Warhouse associate, Lift operator
-
Tyler Macoy
Registered Nurse
-
Steve Newton
Loss Prevention Professional
-
Joey Duran
Security Supervisor
-
Jim McLain
Canyon State Roofing & Consulting
-
Mohamed Amin
Electrical Tech