Advanced Quality Engineer - Actalent

Description:

Job Summary: The Advanced Quality Engineer will play a pivotal role in ensuring the quality and compliance of our medical devices. This position involves leading quality assurance activities, implementing quality systems, and supporting new product development to meet regulatory standards and customer expectations. Key Responsibilities: Lead the development and implementation of Advanced Product Quality Planning (APQP) processes, including PPAP, FMEA, control plans, and capability studies. Review and approve Supplier PPAP packages, ensuring compliance with Level 3 submission requirements. Conduct risk assessments, DFMEA, PFMEA, and process validation for internal and supplier components. Develop and maintain quality documentation, including quality plans, inspection standards, and validation protocols. Collaborate with cross-functional teams to ensure quality requirements are met throughout the product lifecycle. Conduct internal audits and support external audits to ensure compliance with FDA QSR, ISO 13485, and other regulatory requirements. Investigate and resolve quality issues, implementing corrective and preventive actions (CAPA) as needed. Provide training and guidance on quality systems and tools to production and quality engineers. Monitor and analyze quality performance metrics, driving continuous improvement initiatives.

Skills:

Quality engineering, Risk Management, Usability, DFMEA, Design Controls, PFMEA, UFMEA

Top Skills Details:

Quality engineering,Risk Management,Usability,DFMEA,Design Controls,PFMEA,UFMEA

Additional Skills & Qualifications:

Qualifications: Bachelors degree in Engineering, Science, or a related field. Minimum of 5 years of experience in quality engineering, preferably in the medical device industry. In-depth knowledge of FDA QSR, ISO 13485, and other relevant regulatory standards. Proficiency in quality tools and methodologies, including APQP, PPAP, FMEA, SPC, and root cause analysis. Strong problem-solving skills and attention to detail. Excellent communication and interpersonal skills. Certification in quality engineering (e.g., CQE, ASQ) is a plus.

Experience Level:

Intermediate Level

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.