Project Manager

Location: Paramit - Corporate Headquarter
Job Code: 1222
# of openings: 1

Description

Paramit is a rapidly growing international medical device contract design and manufacturing company that designs and manufactures high-quality medical and life sciences instruments. Headquartered in Morgan Hill, CA, we offer a rewarding work environment with global opportunities while maintaining a small company, employee-focused culture. We are seeking an experienced Project Manager for a two-month contract role. We need a PM that is local to the Bay Area, commutable to Morgan Hill, does not require any type of sponsorship and is available to start within the next week.

 

Essential Duties and Responsibilities:

  • Create requirements/plans working with the QA Organization and other functional groups for multiple Quality System improvements project workstreams and tasks to ensure compliance to FDA regulations.
  • Create project plans, resources plans, budgets, and track the projects to align with the expected FDA audit in mid-October.
  • Organize deliverables for rapid retrieval during the audit period. 
  • Ensure completion of tasks post-FDA audit needed to address any remaining tasks or new tasks in response to FDA or internal organization feedback.

 

Minimum Required Education & Experience:

  • BA/BS with at least 5 years of experience in Project Management/Coordination

 

Required Knowledge, Skills & Abilities:

  • Understanding and experience of complex projects spanning several functional organizations.
  • Thorough understanding of complete project management activities such as:
  1. Meeting scheduling and facilitation
  2. Key Progress Indicators and status reporting
  3. Project and Progress monitoring and documentation
  • Ability to create/manage project plans in MS-Project or similar and able to track projects to achieve timely completion within budget with quality
  • Strong organizational skills, able to multi-task and manage multiple workstreams
  • Ability to review/update processes/procedures and organize output for rapid retrieval.
  • Proficient in Microsoft Office, including PowerPoint, Excel, and Word.
  • Maintain a project management office with visual indicators of task status.

 

Preferred:

  • Background or familiarity within FDA Quality Management Systems (21 CFR 820) and ISO 13485 Quality Management System.

 

Working with Paramit you will be at the forefront of technology and a part of making a difference in the medical device and life science instrument industries. These industries touch an immeasurable amount of people, communities, countries, and our world.

At Paramit we are committed to excellence at every level in the organization. As a manufacturer and designer of highly complex, medical devices and life science instruments, we are acutely aware of our responsibility to those who will one day use the products we make. As a result, Paramit is obsessive about doing things the right way, going beyond FDA requirements, and ensuring that every finished product is safe and reliable.

Paramit is a rapidly growing international medical device contract design and manufacturing company that designs and manufactures high-quality medical and life sciences instruments. Headquartered in Morgan Hill, CA, we offer a rewarding work environment with global opportunities while maintaining a small company, employee-focused culture. We are seeking an experienced Project Manager for a two-month contract role. We need a PM that is local to the Bay Area, commutable to Morgan Hill, does not require any type of sponsorship and is available to start within the next week.

 

Essential Duties and Responsibilities:

  • Create requirements/plans working with the QA Organization and other functional groups for multiple Quality System improvements project workstreams and tasks to ensure compliance to FDA regulations.
  • Create project plans, resources plans, budgets, and track the projects to align with the expected FDA audit in mid-October.
  • Organize deliverables for rapid retrieval during the audit period. 
  • Ensure completion of tasks post-FDA audit needed to address any remaining tasks or new tasks in response to FDA or internal organization feedback.

 

Minimum Required Education & Experience:

  • BA/BS with at least 5 years of experience in Project Management/Coordination

 

Required Knowledge, Skills & Abilities:

  • Understanding and experience of complex projects spanning several functional organizations.
  • Thorough understanding of complete project management activities such as:
  1. Meeting scheduling and facilitation
  2. Key Progress Indicators and status reporting
  3. Project and Progress monitoring and documentation
  • Ability to create/manage project plans in MS-Project or similar and able to track projects to achieve timely completion within budget with quality
  • Strong organizational skills, able to multi-task and manage multiple workstreams
  • Ability to review/update processes/procedures and organize output for rapid retrieval.
  • Proficient in Microsoft Office, including PowerPoint, Excel, and Word.
  • Maintain a project management office with visual indicators of task status.

 

Preferred:

  • Background or familiarity within FDA Quality Management Systems (21 CFR 820) and ISO 13485 Quality Management System.

 

Working with Paramit you will be at the forefront of technology and a part of making a difference in the medical device and life science instrument industries. These industries touch an immeasurable amount of people, communities, countries, and our world.

At Paramit we are committed to excellence at every level in the organization. As a manufacturer and designer of highly complex, medical devices and life science instruments, we are acutely aware of our responsibility to those who will one day use the products we make. As a result, Paramit is obsessive about doing things the right way, going beyond FDA requirements, and ensuring that every finished product is safe and reliable.

 





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