Job Information
Actalent Quality Engineer in Elkton, Maryland
Job Title: Complaints Quality Engineer
Job Description
Proactively investigate, identify, and implement best-in-class Quality Engineering practices. Provide focused quality engineering support and assume responsibility for timely and effective coordination and/or execution of assigned development project activities. Establish effective corrective action plans and lead in the implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements. Act as an effective leader or team member in supporting quality disciplines, decisions, and practices. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Identify non-conformance trends and develop technical investigation plans, investigating and analyzing customer/internal complaints. Perform data analysis and execute experiments to qualify or resolve product and process issues. Create, review, and approve internal documentation such as quality plans and standard operating procedures. Develop product/process assurance plans, which include all required elements. Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements. Responsible for developing and implementing master validation plans, validation protocols, inspection plans, and quality/regulatory compliance operating procedures to meet FDA and ISO requirements. Provide training and support for quality system processes and quality engineering practices. Perform other job-related duties.
Hard Skills
Bachelor's or higher in an engineering discipline, preferably Quality Engineering
3-8 years of experience in med device or highly regulated industry
Experience in a fast pace setting where thousands of units are quality checked daily
Knowledge of control plans and their application
Soft Skills
Proactive investigation and identification of best practices
Effective coordination and execution of project activities
Leadership and teamwork in quality disciplines
Systematic problem-solving
Effective communication of quality issues
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 10,000 square feet facility. Working with 10 products with different SKUs and sizes, all related to vascular-access, closure, catheters, embolics, etc. High volume manufacturing environment (e.g., 1 product at 2 million units, another at 1 million units).
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.