Job Title: Senior Quality EngineerJob Description

As a Senior Quality Engineer, you will proactively investigate, identify, and implement best-in-class Quality Engineering practices. You will provide focused quality engineering support and assume responsibility for the timely and effective coordination and/or execution of assigned development project activities. You will establish effective corrective action plans and lead the implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements. Acting as an effective leader or team member, you will support quality disciplines, decisions, and practices. You will apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues. Your role will include reviewing and approving product and process qualifications, validation, and other change control-related documentation. You will develop product/process assurance plans, identifying and implementing effective process control systems to support product development, qualification, and ongoing manufacturing. Your responsibilities will also involve generating internal quality documentation, participating in Product Review Boards, identifying non-conformance trends, and developing technical investigation plans. You will investigate and analyze customer/internal complaints, perform analytical measurements and experiments to qualify or resolve product and process issues. You will develop and implement strategic quality plans, master validation plans, validation protocols, inspection plans, and quality/regulatory compliance operating procedures to meet FDA and ISO requirements. Monitoring quality trends, initiating action items to resolve issues, managing assigned corrective actions, monitoring field quality, analyzing field returns to determine root cause, and providing training and support for quality system processes and quality engineering practices will also be part of your role.

Hard Skills

• Bachelor's or higher in an engineering discipline, preferably Quality Engineering

• 8+ years of experience in med device or highly regulated industry

• Experience in a fast-paced setting where thousands of units are quality checked daily

Soft Skills

• Problem-solving

• Leadership

• Effective communication

• Team collaboration

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

You will work in a new product development environment within a 10,000 square feet facility. The role involves managing 10 products with different SKUs and sizes, all within the vascular category (e.g., access, closure, catheters, embolics). This is a high-volume manufacturing environment, with some products having production volumes as high as 2 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.