Location: Mahwah,NJ, USA
Description:
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+ This function will be directly supporting the EUMDR project on Site.
+ Requirements:
+ Education and Special Training Required: Bachelors Degree in Engineering or relevant field of study Qualifications and Work Experience Required
+ 1-3 years experience in a production/manufacturing environment.
+ Demonstrated computer skills using Microsoft Office applications (Word, Excel, PowerPoint, Project, etc), and experienced work in a Quality Management System and UDI/MDD/MDR/UKCA Regulatory Compliance project experience is preferred.
+ Demonstrated interpersonal, communication and presentation skills. Must be comfortable presenting at team level meetings and lead meetings as necessary.
+ Demonstrate strong teamwork and time management skills as well as be able to operate in a fast-paced environment.
+ Ability to perform in and be challenged by a multi-disciplinary team-based environment, which places a high degree of emphasis on accountability for quality/GMP/GDP compliance.
+ Provide technical support for quality control, process improvement, equipment qualifications, and process validations.
+ Operate within Strykers quality management system (QMS) to produce and/or review documentation such as, inspection guide sheets, product drawings, dynamic control plans (DCPs), and standard operating procedures (SOPs)
+ Periodically work independently with vendors.
+ 2D drawing & GD&T knowledge or experience.
+ Create and manage Engineering Change Requests as well as product impact assessments.
+ Manage Engineering Change Notices for process changes from creation to final approval
+ Demonstrate a general understanding of Product Part Approval Process (PPAP)
+ Demonstrate a general understanding of First Article Inspection (FAI) process
+ Periodically lead projects and processes; work with cross-functional teams to get these projects completed. Ability to multi-task between different projects and changes.
+ Investigate Quality issues for root cause and recommend/implement corrective actions.
+ Ability to oversee team members workload and provide support when issues arise.
+ Work to support team members as both mentor/mentee when necessary.
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 ...@actalentservices.com ( ...@actalentservices.com) for other accommodation options.