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Connexion Systems and Engineering
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Quality Project Manager- EU MDR
$77k-96k (estimate)
Full Time | Business Services 2 Months Ago
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Connexion Systems and Engineering is Hiring a Quality Project Manager- EU MDR Near Providence, RI

Job Title: Quality Project Manager

Location: Providence RI - HYBRID

Pay Rate: $75-85/hr

Quality Project Manager, Cell and Genetic Therapies (Contract)

Summary: This Quality Project Manager will be responsible for supporting cross-functional project teams executing Quality strategies within multiple programs. This individual will work with the Quality leads and interface directly with internal cross-functional teams. This individual will track, report, and project scope/timeline/milestone status associated with qualities projects, Team meetings and external meetings.

Responsibilities:

  • Work closely with area leads to develop and maintain integrated dashboards/ project plans.
  • Identify/communicate interdependencies as well as critical path activities for the project(s).
  • Track and monitor key milestones and decision points and work with team members to meet commitments and drive delivery of objectives.
  • Be the central source of information for the project(s)
  • Effectively communicate with team members, and key stakeholders on the status, objectives, risks, and mitigation plans associated with projects.
  • Organize and maintain team communications including meeting agendas, minutes, decision logs, tasks lists, risk analyses/mitigation strategies, and other relevant materials using preferred technologies to support the project(s) teams.
  • Update and maintain project status tools, such as a project action log, risk register, and dashboards.
  • Assist in the creation and deployment of templates to manage team activities.
  • Consistently perform duties within established SOPs, and in accordance with GxP requirements, where applicable.

Qualifications:

  • Bachelor’s degree in engineering, life sciences or related field. Advanced degree (MS, or MBA) and/or PMP Certification preferred.?
  • A minimum of 6 years of experience in the biopharmaceutical or medical device industry.
  • Previous experience in Quality/Manufacturing/Product Development or EU Medical Device Regulation (MDR) or CE Marking preferred.?
  • A minimum of 3 years of experience in project management of pharmaceutical or medical devices.
  • Experience interacting with Senior Management
  • Working knowledge of cGMPs, and drug/device development lifecycle.
  • Ability to work effectively in a cross-functional, matrixed environment, prioritizing and managing multiple tasks simultaneously, integrating cross-functional issues and balancing competing priorities effectively.
  • Experience independently developing complex project timelines, define project scope, convey timeline visuals (Gantt Charts)
  • Ability to connect enterprise level strategy to project level objectives and clearly communicate and lead project deliverable to meet enterprise objectives and remove roadblocks.
  • Expertise in Microsoft suite (Project, PowerPoint, SharePoint, Word, Excel, Outlook, Teams, OneNote, Visio, PowerBI). Experience with other PM tools a plus (e.g., Think-Cell, OnePager, Office Timeline, etc.).
  • Candidates should possess individual and project organization skills, strong written and verbal communication skills, strong sense of urgency and accountability, ability to respond quickly to requests and efficiently follow up and drive project action completion, should thrive in a faced paced organization and comfortable managing high visibility projects.

Job Type: Full-time

Pay: $65.00 - $75.00 per hour

Benefits:

  • Health insurance

Schedule:

  • Monday to Friday

Education:

  • Bachelor's (Preferred)

Experience:

  • quality in medical device: 5 years (Preferred)
  • EU MDR: 3 years (Preferred)
  • Project Management: 3 years (Preferred)

Ability to Relocate:

  • Providence, RI: Relocate before starting work (Required)

Work Location: In person

Job Summary

JOB TYPE

Full Time

INDUSTRY

Business Services

SALARY

$77k-96k (estimate)

POST DATE

03/06/2024

EXPIRATION DATE

06/29/2024

WEBSITE

csetalent.com

HEADQUARTERS

SUDBURY, MA

SIZE

200 - 500

FOUNDED

1999

CEO

KEN DIMAGGIO

REVENUE

$10M - $50M

INDUSTRY

Business Services

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About Connexion Systems and Engineering

Connexion Systems & Engineering is a consulting organization that provides full service consulting and staff augmentation capabilities to companies all over the United States, across a variety of industries in the following disciplines: o Systems, Software and IT o Engineering and Technical o Scientific and Life Sciences o Field Service o Documentation o Finance and Accounting o Sales and Marketing o Professional and Administrative Founded by respected industry executives in 1999, Connexion Systems & Engineering's Management Team collectively encompasses over 100 years of industry experience. ...This vast knowledge and experience transcends down to our in-house staff, and in turn provides unsurpassed consulting expertise. Follow us on Social Media: o Instagram https://www.instagram.com/connexionsystemsengineering/ o Twitter: @ConnexionStaff ... https://twitter.com/ConnexionStaff o Facebook: https://www.facebook.com/StaffingCSETalent/ More
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