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Hiring for a Quality Engineer!

Job Description

The Process Quality Engineer will be responsible for ensuring that all manufacturing processes meet the stringent quality standards required for Class III medical devices. This role involves developing, implementing, and maintaining quality systems and processes to ensure compliance with regulatory requirements and industry standards.

Responsibilities

+ Develop and implement process validation protocols and reports (IQ, OQ, PQ) to ensure manufacturing processes are capable and compliant.

+ Conduct root cause analysis and implement corrective and preventive actions (CAPA) to address process-related quality issues.

+ Collaborate with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs, to ensure product quality and compliance.

+ Monitor and analyze process performance data to identify trends and areas for improvement.

+ Lead process improvement initiatives to enhance product quality, reduce waste, and increase efficiency.

+ Ensure compliance with FDA regulations and other applicable standards.

+ Participate in internal and external audits, providing necessary documentation and support.

+ Train and mentor production staff on quality standards and best practices.

Essential Skills

+ Quality engineering

+ Quality assurance

+ Supplier quality

+ Medical Device QE background

+ Quality Assurance

+ Supplier/Manufacturing Quality Support

+ PPAP

+ Root cause analysis

+ Audit

+ Medical device

+ CAPA

+ Quality control

+ Quality management

+ ISO

+ PFMEA

+ 5+ years experience

Additional Skills & Qualifications

+ Experience in developing and implementing process validation protocols and reports (IQ, OQ, PQ)

+ Ability to conduct root cause analysis and implement corrective and preventive actions (CAPA)

+ Strong collaboration skills with cross-functional teams

+ Experience in monitoring and analyzing process performance data

+ Leadership in process improvement initiatives

+ Knowledge of FDA regulations and other applicable standards

+ Experience participating in internal and external audits

+ Ability to train and mentor production staff on quality standards and best practices

Pay and Benefits

The pay range for this position is $60.00 - $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 Boulder,CO.

Application Deadline

This position is anticipated to close on May 23, 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.

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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.