EQVAL Group, Inc. is a company that provides services to the manufacturing industry ( Medical Devices, Pharmaceuticals, Biotechnologies, others ).
We work with an extraordinary group of professionals ( employees and contractors ) to accomplish the requirements established by our customers, in order to perform and provide a highly effective service.
We are looking for a P roject Manager that will be working on a Medical Device manufacturing environment to support a transfer project.
Must have experience with EU MDR remediation, managing documents within an electronic PLM system and proven experience in project management.
Education / Experience BS in Science or Engineering (Mechanical, Biomedical, etc.).
5–7 years in medical device/pharma manufacturing, with at least 5 years in process/quality/validation roles.
Experience with EU MDR remediation, compliance projects, and managing documents within an electronic PLM system .
Proven experience in project management, including planning, executing, and closing projects in a regulated environment.
Strong knowledge of EU MDR 2017/745, ISO 13485:2016, and FDA regulations.
Proficient with Minitab or equivalent for statistical analysis.
Skilled in creating Change Controls, Validation Plans, SOPs, and technical documentation.
Excellent communication skills, both in English and Spanish.
Analytical problem-solving and ability to work independently or in teams.
Flexible with extended hours and weekends as needed.
Responsibilities Data Gathering: Assist in compiling documentation for EU MDR compliance.
Mfg Documentation & Routers Update: Update manufacturing records and production instructions for on-demand label systems (Kallik/Loftware, Oracle).
Project Implementation: Lead the generation and execution of change controls, technical reports, and documentation updates via the Agile system.
Cross-functional Collaboration: Work with various departments to ensure project milestones are met on schedule.
Project Tracking: Monitor and report on project progress, ensuring timelines, budgets, and quality standards are met.
Risk Management: Identify project risks and implement mitigation strategies to keep the project on track.
Stakeholder Communication: Regularly update stakeholders on project status, ensuring alignment across teams.
Benefits: Dental insurance Health insurance Life insurance Paid time off Professional development assistance Referral program Schedule: 8 hour shift Day shift Monday to Friday Work setting: In-person Powered by JazzHR