Quality Auditor

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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,

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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.  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…