Senior Complaints Quality Engineer

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 ( ) for other accommodation options.

Created: 2024-10-19