Job Information
Actalent Senior Complaints Quality Engineer in Elkton, Maryland
Job Title: Sr Complaints Quality Engineer
Job Description
The Sr 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 Skills
Engineering support in post-market surveillance
Complaint investigations
Product evaluations
Root cause analysis
Complaint trend analysis
Decontamination and testing of returned devices
Data analysis
Simulation testing
Root cause investigation and resolution
Failure analysis techniques
Process improvements
Quality documentation generation
Non-conformance trend identification
Technical investigation plans
Quality trend tracking
Corrective action management
Customer and field associate response preparation
Support for internal and third-party audits
Training and support for quality system processes
Minimum of a 4-year degree in Mechanical Engineering, Biomedical Engineering, or equivalent discipline
8+ years of experience in a medical device quality assurance environment
Working knowledge of FDA's QSRs, ISO :2003, MDD, and other national/international regulatory quality system requirements
Soft Skills
Mentoring complaint engineers
Effective coordination of project activities
Continuous improvement advocacy
Communication skills
Quality performance enhancement
Participation in Quality Management Reviews
Coordination and hosting of post-market data reviews
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 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.