Quality Manufacturing Engineer

Actalent • Irvine, CA • 3w ago

Immediate Quality Manufacturing Engineering Opportunity!

For Immediate consideration please email your resume to habels@actalentservices.com

Job Description

As a Quality Manufacturing Engineer, you will lead operations and oversee manufacturing processes, ensuring quality control and regulatory compliance at every stage. You will drive process improvements, conduct risk assessments, and collaborate with suppliers to enhance product quality. Your role will be pivotal in supporting audits, conducting root cause analyses, and coordinating product testing.

Responsibilities

Provide manufacturing oversight for upstream and downstream processes.

Support engineers in monitoring and implementing quality control measures to ensure compliance with regulatory standards and internal requirements.

Lead engineers in identifying and implementing process improvements to enhance product quality, reduce waste, and optimize manufacturing efficiency.

Conduct risk assessments related to manufacturing processes and identify areas for risk mitigation.

Stay current with regulatory requirements and ensure manufacturing processes adhere to these regulations.

Collaborate with supplier engineering groups to assess and improve the quality of incoming components and materials.

Investigate and resolve quality issues by performing root cause analysis and implementing corrective and preventive actions.

Support internal and external audits, including FDA inspections, by providing documentation, data, and expertise related to manufacturing quality.

Oversee and coordinate product testing, validation, and verification processes to ensure products meet required specifications.

Essential Skills

8-10 years of experience working as a Quality Engineer in the medical device industry.

Experience with Class II or Class III medical devices, particularly catheters.

Proficiency in ISO standards, equipment qualification, process validation, test method validation, non-conformances, CAPA, and root cause analysis.

Knowledge of risk management, cleanroom protocols, statistical analysis, BOM, and DMR.

Bachelor's Degree in Engineering or a related field.

Excellent communication and technical writing skills for documentation duties, reviewing procedures, preparing reports, and collaborating with cross-functional teams.

Additional Skills & Qualifications

Experience in quality and manufacturing roles within the medical device industry.

Proven track record in quality control and process improvement.

Work Environment

You will work in a medical device manufacturing environment, specializing in cardiovascular and endovascular solutions. The team consists of three members. You will be required to gown up for cleanroom activities up to six times daily in a Class 8 cleanroom. Your time will be split 50/50 between manufacturing and cleanroom floors versus desk work. Standard hours are Monday to Friday, 8:00 AM to 5:00 PM, with some the person as needed to meet project deadlines. The environment is collaborative and fast-paced, supporting a company that is rapidly growing and expanding its production capabilities.

Pay and Benefits

The pay range for this position is $45.00 - $76.00/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 Irvine,CA.

Application Deadline

This position is anticipated to close on Apr 22, 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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