Job Title: Quality Engineer
Job Description
The Quality Operations Specialist / Quality Engineer will be responsible for performing daily quality engineering work in manufacturing areas to provide direct support for all manufacturing activities from a quality standpoint. The role involves monitoring manufacturing process verifications to ensure compliance with operating procedures and specifications. Additionally, the specialist will manage process monitoring, labeling control, reinspection process monitoring, and sampling processes for reserved samples. Quality oversight on manufacturing processes to ensure compliance, including data integrity, and support for all investigations and resolution of quality issues is also required.
Responsibilities
Perform daily quality engineering work in manufacturing areas.
Monitor manufacturing process verifications to ensure compliance with operating procedures and specifications.
Manage process monitoring, labeling control, reinspection process monitoring, and sampling processes for reserved samples.
Provide quality oversight on manufacturing processes to ensure compliance, including data integrity.
Support investigations and resolution of quality issues.
Conduct root cause analysis and implement corrective and preventive actions (CAPA).
Perform audits and ensure compliance with FDA regulations.
Handle risk mitigation, non-conforming material reports (NCMR), and product discrepancies.
Support change control and production line activities.
Review drawings and procedures to ensure quality standards.
Essential Skills
Quality engineering
Quality assurance
Root cause analysis
Audit
Medical device industry experience
Investigations
CAPA (Corrective and Preventive Actions)
FDA regulations compliance
Risk mitigation
NCMR (Non-Conforming Material Reports)
Product discrepancies handling
Change control
Production line support
Quality control
Additional Skills & Qualifications
Engineering degree
2 or more years of relevant experience
Work Environment
The position is based in an on-site manufacturing environment. The team consists of 64 members, including technicians and supervisors, responsible for managing everything from raw materials to finished products. The role includes reviewing drawings and procedures . The company develops, manufactures, and markets innovative medical products and services to the healthcare industry, addressing significant challenges such as opioid abuse, hospital-acquired malnutrition, and hazardous drug exposure.
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 (% ) for other accommodation options.