Quality Systems Engineer

We’re ALTEN Technology USA, an engineering company that provides solutions for engineering, technology, and product development projects. For decades, we’ve been helping our clients develop products that are changing the world, whether that’s by shaping the future of space exploration, saving lives with medical devices that set a new standard of care, or creating the fully autonomous electric taxi of tomorrow. Our team of more than 600 people works across industries including aerospace, medical devices and life sciences, unmanned systems and robotics, automotive OEM and tier 1 suppliers, commercial vehicle, electric vehicles, rail, and more. Our offices across the US have different industry focuses and engage with our clients in different ways, ranging from working on-site at client facilities to performing product development at our delivery centers.
 
ALTEN Group, our parent company, has been a leader in engineering and information technology for more than 30 years. ALTEN Group operates in 30 countries across Europe, North America, Asia, Africa and the Middle East and employs more than 36,000 people, 88% of whom are engineers. The company covers the whole development cycle and offers a choice of service levels, from technology consulting to complete project outsourcing.
 
When you join ALTEN Technology USA, you join a group of people passionate about collaborating to solve some of the world’s most technical engineering challenges. Our success is tied to taking care of our employees by building relationships and providing opportunities for mentorship and career growth. We offer comprehensive benefits for all full-time employees, including medical, dental, and vision insurance; a 401(k) plan with employer matching; paid time off (PTO); paid parental leave; and mentorship to help you take your career to the next level. You don’t have to take our word for it that we are a great place to work—we were named on the 2023 Top Workplaces list thanks to feedback from our proud employees.

We are seeking a detail-oriented and collaborative Quality Systems Engineer to support the implementation, qualification, and maintenance of various Quality and Building Management Systems (QBMS). The ideal candidate will have a strong understanding of cGMP requirements, a proactive approach to change control, and the ability to communicate effectively across cross-functional teams. This role requires experience with regulated manufacturing environments and systems validation.

Responsibilities;

• Collaborate with site teams to implement and qualify QBMS systems across various operational phases.

• Execute and manage change control and CAPA assignments in TrackWise.

• Review and approve qualification documentation within Kneat.

• Ensure compliance with cGMP procedures, Quality Systems, and Good Documentation Practices (GDP).

• Support the qualification of systems including but not limited to: QBMS1990, QBMS3990, QBMS4990, QBMS6990, QBMS7990, and QBMS8990.

• Perform system modifications, additions, or decommissioning tasks as part of change control processes.

• Provide flexible support aligned with production schedules, site shutdowns, or other critical inputs.

Qualifications;

• Bachelor's degree in engineering, life sciences, or a related technical field.

• Experience with cGMP regulations and compliance within a manufacturing environment.

• Familiarity with computerized systems such as TrackWise and Kneat.

• Strong communication skills, both oral and written, with the ability to work effectively across departments.

• Detail-oriented and capable of managing multiple priorities in a fast-paced setting.

• Flexibility to support occasional extended or off-hour work based on site needs.

The actual salary offered is dependent on various factors including, but not limited to, location, the candidate’s combination of job-related knowledge, qualifications, skills, education, training, and experience.

ALTEN Technology is an Equal Opportunity Employer. Our Policy is to extend opportunities to qualified applicants and employees on an equal basis regardless of an individual’s age, race, color, sex, religion, national origin, disability, sexual orientation, gender identity/expression or veteran status.

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