Quality Auditor

Kelly Science, Engineering, Technology & Telecom; Clearwater (FL); On-site; USD 80,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Short-term disability and life insurance

Retirement savings plan

Paid holidays and sick leave

Job summary

A leading medical device company in Clearwater seeks a Quality Auditor responsible for compliance audits and quality system improvements. The ideal candidate has a Bachelor’s degree, quality auditing certification, and extensive experience in quality-related functions in regulated environments. This full-time position offers a competitive hourly rate and the opportunity to influence quality enhancements until 2025, potentially extending into 2026.

Qualifications

• 5-7 years’ experience in Quality related function in a pharmaceutical/medical device environment.
• Minimum 3 years auditing GMP/ISO quality systems.
• Experience interacting with regulatory bodies during inspections.

Responsibilities

• Lead and conduct internal and supplier audits for compliance.
• Prepare detailed audit reports and track corrective actions.
• Identify gaps or risks and provide recommendations for quality improvements.

Skills

Interpersonal skills

Communication skills

Education

Bachelor's degree in technical field

Certification in quality auditing (e.g., ASQ CQA, ISO 13485 Lead Auditor)

Job description

1 week ago Be among the first 25 applicants

Kelly Science & Clinical is seeking a Quality Auditor for our client a leading medical device company in Clearwater, Florida. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Expert

Schedule: On-site Monday through Friday 8am to 5pm

Length of assignment: Until the end of 2025, may extend into 2026

Pay: $40 an hour

Responsibilities

• Lead and conduct internal and supplier audits to determine the state of compliance and drive improvement in Quality Systems
• Responsible for leading and conducting internal quality system audits (planning, executing, and reporting) on internal audits to assure that all departments implement and maintain an appropriate quality system and adhere to polices and the laws and regulations of the countries in which products are produced and marketed.
• Responsible for leading and conducting audits of contract manufacturers and suppliers relative to corresponding quality systems and regulatory standards and requirements. This includes audit planning, execution, documentation and reporting with proactive follow up with corrective action /preventive actions (CAPAs).
• Prepare detailed audit reports and track CAPA and contribute to ongoing QMS enhancements.
• Responsible for the communication and documentation of internal and external compliance- related information including changes in regulations, new guidelines and guidance documents and other information from regulatory authorities and trade organizations.
• Inform management on an ongoing basis about the compliance status in all areas of the business and highlight any delays and resource constraints that could adversely impact the business.
• Identify gaps or risks, provide recommendations for corrective actions, and support continuous improvement initiatives to uphold product safety, quality, and regulatory compliance.
• Collaborate with cross-functional teams to implement quality improvements.
  
  

Requirements:

• Bachelor's degree in technical field required. Experience and certification may be considered in lieu of a degree.
• Certification in quality auditing (e.g., ASQ CQA, ISO 13485 Lead Auditor) required
• Highly developed interpersonal skills as well as strong written and oral communication skills.
• Demonstrated hands on ability to lead cross functional audit teams.
• Experience interacting with the regulatory bodies during inspections is also desirable.
• Working knowledge and experience in a regulated medical device or pharmaceutical industry and experience with managing external agency audits necessary.
• 5-7 years’ experience in Quality related function in a pharmaceutical and or medical device environment, responsible for developing and implementing quality systems. Minimum 3 years auditing GMP/ISO quality systems.
  
  

What happens next

Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry—even if this position doesn’t work out, you’re still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more.

Helping you discover what’s next in your career is what we’re all about,

#P1

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science

• Industries

  Staffing and Recruiting

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