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Kelly Services Quality Assurance Associate in Broomfield, Colorado

Quality Assurance Associate

Pay depended on experience

Temporary Help until Feb 2021 with a possibility to be permanent

Monday-Friday 8-5

Oversees Quality Assurance activities to ensure compliance with regulatory agencies, ISO and Company requirements. Performs a broad range of tasks which may include risk management, validation, maintenance, support, training, and implementation and maintenance of Quality Systems, Policies, and Procedures.

Duties:

  • Supports the implementation and maintenance of the Quality System.

  • Final disposition authority for incoming materials, including packaging and labeling, used in product manufacturing.

  • Responsible for reviewing manufacturing documentation with a presence on the manufacturing floor.

  • Oversee Purchasing Controls for critical A and B materials in accordance with the Approved Vendor list and regulatory requirements.

  • Manage the Approved Vendor List, additions and removals.

  • Review and final approval authority for device history records, new documents/new document revisions prior to distribution.

  • Assist in establishing and maintaining document approval and change control procedures.

  • Manage filing, database inputs, and approval of quality documents (e.g. NCR, PDN, RP, housekeeping records, Material Action Tickets, Action Impact Reviews, device history records).

  • Coordinates and maintains the Corrective and Preventive Action (CAPA) process to ensure compliance to regulatory and internal requirements and to ensure actions are completed in a timely manner.

  • Manages the nonconformance handling system to ensure all nonconformities are identified, investigated and entered into the CAPA system, if necessary.

  • Conduct and assist as needed with the Company Internal Audit Program.

  • Maintain the Company Training Program and assist with company awareness of the Company Quality System and provide support and training on Quality issues.

  • Oversee Metrology Program – Work Order approval/closure.

  • Other duties as assigned by Supervisor.

Qualifications

KNOWLEDGE: The position requires excellent knowledge of FDA and international regulations, directives and standards governing medical devices.

EXPERIENCE: This position requires a minimum of three (3) years’ experience in Quality Assurance or Regulatory Affairs in an FDA regulated industry plus an Associate’s Degree -or-

A minimum of (6) years’ experience in Quality Assurance or Regulatory Affairs in an FDA regulated industry.

BS in Science or related field

The position requires strong communication and interactive skills in cross functional participation and must demonstrate the ability to work and think independently. This person must also have the ability to investigate and resolve quality problems.

Why Kelly ® ?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly ®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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