Director of Quality Job Listing at Kelly Services in Broomfield, CO (Job ID 9554111)

Description

Director of Quality – Broomfield, CO

Type: Direct Hire
Shift: M-F, 1st, Hybrid (3/2)
Salary: 110-150K DOE

Role and Responsibilities:

• Establish, maintain, and continuously improve the Quality Management System (QMS) to ensure compliance with CAP, ISO15189:2012, and regulatory requirements.
• Prepare reports and conduct Management Review Meetings to assess quality and performance.
• Coordinate the Corrective and Preventive Action (CAPA) process, managing nonconformities and ensuring timely resolution.
• Oversee Internal Quality Assessments, Interim Self-Inspections, and external audits, including CAP and ISO assessments, and customer audits.
• Manage the vendor system to ensure effective control and surveillance of critical suppliers of materials and services.
• Ensure personnel are properly trained on QMS procedures and maintain accurate training documentation.
• Review and resolve complaints and ensure adherence to regulatory requirements.
• Monitor test performance and equipment validations, calibrations, and preventive maintenance, ensuring compliance with established performance specifications.
• Oversee document change orders, ensuring quality and compliance throughout the process.
• Allocate resources, administer laboratory services, and manage budget planning, while providing ongoing education on CLIA compliance.

Qualifications

• Minimum of five (5) years of experience related to Quality Assurance or Regulatory Affairs in a regulated industry plus a Bachelor's Degree
  -OR-
• A minimum of seven (7) years of experience related to Quality Assurance or Regulatory Affairs in a regulated industry.
• Strong communication and leadership skills
• Ability to investigate and resolve quality problems
• Strong auditing knowledge and experience is also required.

Additional Notes:

• This is a hybrid position requiring on-site presence for three days a week, with the ability to work remotely two days a week. A remote work policy agreement will be signed by the employee and their manager.

Apply today to be considered! 

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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. 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's 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.

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