Top 8 Quality assurance specialist Jobs in Gainesville, Fl

QA PM Specialist
Advita Ortho —Gainesville, FL
- Full-time
- Mid-level
- Windows
- Analysis skills
Quick Apply
13d
Senior Quality Specialist, Quality Operations
Ascend Advanced Therapies FL, Inc. —Alachua, FL
- Full-time
- Hybrid work
- 5 years
- Bachelor of Science
- Bachelor's degree
- Health savings account
- Health insurance
Quick Apply
Embroidery Quality Control Specialist
Top Tier Graphics Inc —Newberry, FL
- From $15.25 an hour
- Overtime
- High school diploma or GED
- Organizational skills
- Warehouse experience
- Paid holidays
- 401(k)
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6d
Commercial Nuclear Quality Assurance Specialist (Nuclear Software QA)
Johnson Service Group Inc. —United States
- Up to $100 an hour
- Contract
- Remote
- 5 years
- Bachelor of Science
- Writing skills
- Disability insurance
- Health insurance
Quick Apply

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Quality Assurance Specialist
Hims & Hers —New Albany, OH
Bachelor’s degree in Quality Assurance, Data Analytics, Engineering, Life Sciences, or a related field required. Employee Stock Purchase Program (ESPP).
4d
Workplace Solutions - Quality Assurance Specialist (Service Desk)
JPMorganChase —Columbus, OH
The QA Specialist will monitor inbound/outbound calls and written interactions (email/tickets) to evaluate professionalism, technical accuracy, customer service…

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QA PM Specialist

Advita Ortho
Gainesville, FL

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Job Details

Full-time
13 days ago

Qualifications

ISO standards
Windows
Desktop applications
Biomedical regulatory compliance
Productivity software
Regulatory compliance analysis
Associate's degree
Technical Proficiency
Quality data entry

Full Job Description

Description

The purpose of the QA Post Market Specialist is to perform complaint handling activities to ensure regulatory compliance and customer satisfaction. This role coordinates and submits regulatory reports to FDA and Country/Regional competent authorities.

Key Responsibilities

Engaged in the receipt, documentation, investigation, and closure/resolution of customer complaints to ensure regulatory compliance (e.g., FDA, CMDR, ISO) and customer satisfaction.
Adhering to all Advita procedures and requirements. Assesses complaint events for regulatory reporting requirements.
Submits regulatory reports to FDA or Regional Competent Authority within regulatory timeframes.
Escalates high severity events and cases to Management.
Supports the completion of complaint activities in line with department metrics and key performance indicators.
Supports audits and audit requests for complaints.
Assists with continuous improvement activities and/or special projects, as assigned.
Assists in training complaint team members.
Assists in updates or creation of procedures, work instructions, forms, reports and letter templates to standardize departmental processes.
Knowing and applying Advita’s Quality System and any appropriate FDA and international standards.
Assist and support other employees, teams, and sales personnel, as necessary.

Skills Knowledge and Expertise

Education:

Associate's Degree from an accredited institution required; Bachelor's Degree preferred.

Experience:

Degree in Allied Health, Statistics, Epidemiology, Life Sciences or Biomedical Engineering, highly preferred.
Minimum of 1 year of experience performing a complaint handling or post market surveillance role in a Medical Device or Pharmaceutical FDA regulated environment.
In lieu of previous complaint handling experience, 2 years of experience in a quality assurance role in the Medical Device or Pharmaceutical FDA regulated environment.
Working knowledge of requirements of FDA, EU, and other global regulations related to complaint handling and Recalls/FSCA required.
Experience with FDA/ISO quality management system regulations required.

Functional/Technical Knowledge, Skills and Abilities Required:

Working knowledge/skill in Windows-based office productivity tools.
Excellent analytical skills and detail-oriented.
Strong organizational and time management skills.
Strong written, oral, and presentation communication skills. Ability to consistently meet high standards of input accuracy, produce quality documents, compile data, and perform simple analyses with accuracy. Self-directed; capable of setting own priorities and working independently to meet established deadlines.

About Advita Ortho

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quality assurance specialist jobs in gainesville, fl

QA PM Specialist

Senior Quality Specialist, Quality Operations

Embroidery Quality Control Specialist

Commercial Nuclear Quality Assurance Specialist (Nuclear Software QA)

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Key Responsibilities

Skills Knowledge and Expertise

About Advita Ortho

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