Quality Systems Engineer
2 weeks ago
Job Title: Quality Systems Engineer
Job Description
Develops strategy and leads Quality & Compliance functions for the business to maintain a high state of compliance and ensure business needs are met by providing appropriate oversight for day-to-day business and for business change initiatives. Works with other departments such as R&D, Regulatory, Supplier Quality, LCM, Marketing, and Supply Chain to develop strategy. Supports regulatory compliance audits. Conducts Quality System and Quality Manual development. Assists with the creation and modification of Quality System procedures, work instructions, and related documentation as needed. Provides input and development of Intra Company Quality Agreements. Ensures compliance with regulatory agency regulations and standards. Provides solutions to a variety of problems of moderate scope and complexity. Communicates business-related issues or opportunities to the next management level. Ensures personal and company compliance with all Federal, State, local, and company regulations, policies, and procedures. Performs other duties as assigned.
Hard Skills
+ Systems Quality
+ QMS
+ Medical Device
+ Need someone strong in Compliance, Quality assurance, and some Regulatory affairs
+ Experience with Auditing and personnel training
+ Knowledge of working with a Quality plan, updating procedures (SOPs)
+ Knowledge of quality areas for R&D and manufacturing (NOT post market)
+ R&D moving sites, Technology Transfers, site transfers, and Decommissioning of a site would be a huge plus
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.
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