Quality Engineer

Quality Engineer Opportunity with Medical Device Manufacturer in Miami! Hybrid schedule.

In this exciting role as Quality Engineer you will develop modify apply and maintain quality standards and protocols for post market analysis. Perform complex failure analysis of devices/components returned with alleged malfunctions. Collaborates with engineering product development complaint management supplier quality and manufacturing functions to ensure returned product investigations fully address reported events. Develop and implement methods and procedures to assist in product analysis investigations. Provide direction for failure analysis technicians to ensure that field returns are evaluated appropriately to deliver clear investigation results and potential root causes for identified failures. Initiate discussions with management Field Assurance and QA when new failure modes is are identified during failure analysis.

Collaborates with engineering and manufacturing functions to ensure quality standards are in place.

Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

May specialize in the areas of design incoming material production control product evaluation and reliability inventory control and/or research and development as they apply to product or process quality

Completes comprehensive review log files to determine correlation between the reported event and electro-mechanic components.

Reviews system testing results including but not limited to: profilometer measurements front/back impeller pre-loads axial gap measurements in-vitro wet-test functional parameters and stators conductivity results to determine a most probable root cause associated with a reported event.

Determines potential interaction between reported event and all system components controller batteries pump monitor AC adapter batterie charger and surgical tools.

Generates comprehensive product investigation reports to support findings root cause regulatory requirements and obtains the necessary release approvals.

Creates and develops engineering projects for improvements of analysis/investigation process to eliminate process waste and reduce rework rates.

Participates and/or conducts validation or qualifications tests of new or existing failure analysis equipment in accordance with internal procedures.

Qualification

Medical device experience

Complaint handling experience preferred

Product Risk Management experience/Post market quality experience preferred

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 ~~~ (~~~) for other accommodation options.