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Actalent · 2 days ago
Quality Systems Engineer
Miami, FL
Contract
Onsite
Senior Level
6+ years exp
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Responsibilities
Develop strategy and lead Quality & Compliance functions for the business
Work with other departments to develop strategy
Support regulatory compliance audits
Conduct Quality System and Quality Manual development
Assist with creation and modification of Quality System procedures and documentation
Provide input and development of Intra Company Quality Agreements
Ensure compliance with regulatory agency regulations and standards
Provide solutions to problems of moderate scope and complexity
Communicate business related issues or opportunities to next management level
Ensure personal and Company compliance with all regulations, policies, and procedures
Perform other duties as assigned
Qualification
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Required
A minimum of bachelor’s degree is required
A minimum of 6-8 years of experience in related field and/or equivalent experience in the medical device industry is required.
Experience with FDA regulations for medical devices is required.
Experience with ISO 13485: 2016 is required.
Knowledge of the European MDD, MDR and CE marking is required.
Experience working as a member of a team in a timeline-driven environment with limited supervision is required.
Good Quality Systems Knowledge
Preferred
Project Management experience is preferred.
Demonstrated leadership, organizational, and planning skills with the ability to work cross-functionally with a culturally diverse work force and customer base is preferred.
Benefits
Health Insurance
Company
Actalent
Actalent is an engineering and sciences service company.
5,001-10,000 employees
H1B Sponsorship
Actalent has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (31)
2022 (63)
2021 (20)
Funding
Current Stage
Late StageLeadership Team
Scott Anderson
Chief Financial Officer
Alison Deming Bucek, SPHR, SHRM-SCP
Human Resource Business Partner
Recent News
Company data provided by crunchbase
