Job Title: Senior Complaints Quality Engineer
Job Description

The Senior Complaints Quality Engineer will provide engineering support in post-market surveillance, with a focus on complaint investigations, product evaluations, root cause and complaint trend analysis. The associate is responsible for planning and coordinating the daily complaint engineering activities and is accountable for managing the complaint engineers' time efficiently and effectively to meet specific quality metrics related to complaints. The associate will advocate for the execution of initiatives and projects to enhance quality performance as part of Continuous Improvement.

Hard SkillsEngineering support in post-market surveillanceComplaint investigationsProduct evaluationsRoot cause analysisComplaint trend analysisDecontamination and testing of returned devicesData analysisSimulation testingRoot cause investigation and resolutionFailure analysis techniquesProcess improvementsQuality documentation generationNon-conformance trend identificationTechnical investigation plansQuality trend trackingCorrective action managementCustomer and field associate response preparationSupport for internal and third-party auditsTraining and support for quality system processesMinimum of a 4-year degree in Mechanical Engineering, Biomedical Engineering, or equivalent discipline8+ years of experience in a medical device quality assurance environmentWorking knowledge of FDA's QSRs, ISO :2003, MDD, and other national/international regulatory quality system requirementsSoft SkillsMentoring complaint engineersEffective coordination of project activitiesContinuous improvement advocacyCommunication skillsQuality performance enhancementParticipation in Quality Management ReviewsCoordination and hosting of post-market data reviewsJob 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 000 square feet facility. 10 products with different SKUs and sizes, all vascular-related (access, closure, catheters, embolics, etc.). High volume manufacturing environment with products ranging from 1 to 2 million units. Examples include vascular closure devices used for therapies such as stent placement.

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.