Job Title: Complaints Quality Engineer IIJob Description

The Complaints Quality Engineer II is responsible for the analysis, evaluation, and product investigation of complaints received from external customers in compliance with FDA, ISO, QSR, and other regulatory guidelines. The role involves driving all complaint investigation activities with cross-functional team members, preparing investigation reports, assigning tests on retention and returned samples, and writing customer letters. This position supports and assists in the evaluation of Complaints for Medical Device Report (MDR) and Vigilance (MDV) reports. The engineer will interact with medical professionals, marketing, customers, customer service, clinical, regulatory, R&D, and management to support complaint investigations.

Hard Skills

• Minimum of a 4-year degree in engineering, life sciences, or equivalent technical degree

• Three to six years’ experience in a medical device quality assurance or clinical environment

• Clinical Experience or in-depth knowledge of interventional products & medical procedures

• Six Sigma Green Belt Qualification and/or ASQ CQE qualification desirable

• Minimum of 4 years’ experience in quality, customer complaint investigation/resolution, or clinical experience in the medical device industry (disposable devices)

Soft Skills

• Ability to work in a team environment

• Strong analytical and problem-solving skills

• Effective communication skills with various stakeholders

• Capability to work independently and resolve complex issues

• Proficiency in presenting critical information and training others

Job Type

This is a Contract-to-Hire position with a duration of 9 Month(s).

Work Site

This is a hybrid position requiring some days on-site in Elkton, Maryland and some days remote.

Work Environment

New product development in a high-volume manufacturing environment. The company handles 10 products with different SKUs and sizes, including vascular access, closure devices, catheters, embolics, etc. Examples include manufacturing a vascular closure device used in artery procedures.

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.