Job Title: Quality Engineer

Job Description

The Quality Engineer will support manufacturing operations by conducting process validations and overseeing line transfer projects. This role requires leading the process for closing out Corrective and Preventive Actions (CAPAs) and Non-Conformance Reports (NCRs) in a timely manner.

ResponsibilitiesSupport manufacturing operations with process validations and line transfer projects.Lead the process for closing out CAPAs and NCRs promptly.Manage vendor procurement and change notifications.Oversee Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) processes.Handle project management tasks and technical writing for regulatory submissions.Manage document change orders and ensure compliance with medical device regulations.Essential SkillsExperience with NCR, vendor procurement, and change notifications.Proficiency in IQ/OQ/PQ processes.Strong project management skills.Technical writing for regulatory submissions.Experience with CAPA and document change orders.Knowledge of line transfer processes.Familiarity with medical device regulations (820).Additional Skills & QualificationsMedical device experience is strongly preferred.Open to candidates from automotive and aerospace industries due to their regulated nature.Project management certification (CAPM, PMI) is a plus but not required.Preference for candidates from small companies or startups, but open to those from larger companies with diverse experience.Strong background in cross-functional teamwork.Work Environment

The role requires the ability to travel up to 20% of the time. The company offers a growth-focused, flexible work environment despite being a large team (1,000+ employees). The company operates on a beautiful campus and is expanding with the construction of a new building. The company has shown remarkable growth during the pandemic and maintains a healthy business outlook.

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 for other accommodation options.