Description:

• Assist with the maintenance of the quality system to domestic and international standards, including ISO 13485.

• Create and revise quality documentation such as standard operating procedures, inspection procedures, inspection data sheets, etc.

• Maintain quality documentation in accordance with cGMPs, FDA, ISO, and other pertinent regulatory authorities.

• Provide training to personnel on quality system documents.

• Comply with design control procedures and all applicable regulatory guidelines when working on product designs.

• Create and maintain product quality plans to document key quality characteristics, as well as, the methods, equipment, and sample sizes required to measure the key quality characteristics.

• Identify and execute continuous improvement activities to enhance product quality.

Skills:

Quality assurance, Inspection, audit, iso 13485, gmp, Quality inspection, capa, documentation control, Non conforming

Additional Skills & Qualifications:

• Bachelor’s degree in science, engineering, or other technical field required.

• Minimum of 1-3 years experience working in a manufacturing environment. (Desired manufacturing environments: small electronics, automotive, aerospace, medical device, metals)

• Experience working in a regulated and certified company (medical device, aerospace, pharmaceutical, ISP 9001, ISO 13485)

• Proficient Microsoft Office Suite skills (Word, Excel, Outlook, PowerPoint)

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.