Job Title: Quality Manager

Job Description

Develop and implement a quality management system that complies with ISO:2016 and FDA regulations. Conduct internal and external quality audits, manage the supplier quality system, and lead and develop the quality team.

Responsibilities

• Develop and maintain a quality management system in compliance with ISO:2016 and FDA regulations.
• Conduct internal and external quality audits to ensure adherence to standards.
• Manage and improve the supplier quality system.
• Lead and develop the quality team, providing guidance and support.
• Ensure compliance with FDA inspections and audits.

Essential Skills

• Strong knowledge of ISO:2016 and FDA regulations for Class III medical devices.
• Experience in quality management roles for FDA inspections or audits.
• Minimum of 5 years managing direct reports.
• Expertise in ISO and FDA inspections, audit management, and quality management.

Additional Skills & Qualifications

• Bachelor's or Master's degree in Engineering or related field.
• Minimum of 5 years in quality management within the medical device industry.
• Minimum of 5 years managing a team.
• Knowledge of FDA Quality System Regulation (QSR).
• Experience with Class III medical devices.

Work Environment

This role is based in a medical device manufacturing environment. The facility includes various clean room setups across multiple buildings within the business park. The team size ranges from 6 to over 20 individuals, including design engineering, manufacturing, and document controls.

Pay and Benefits

The pay range for this position is $52.40 - $65.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Longmont,CO.

Application Deadline

This position is anticipated to close on Feb 9, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $52 - $65