and those authorized to work in the U.S. can be considered as W2 candidates.
Job Title: Quality Project Manager
Location: Norwood, MA 02062
Duration: 5+ Months
Schedule: Shift 1; M-F (8:00 AM - 5:00 PM)
Per manager: "SAP knowledge is a must Document Control knowledge is a must Proven success of project management is required."
• The Quality Project manager will lead the management and execution of Quality Management sub-system initiatives.
• Specifically, the person will be required to interact and manage a cross functional team to promote and drive Quality Systems compliance regarding Design Control and Documentation Control.
• Additionally, this role will support specific quality improvement projects as required for QT and other business initiatives.
• The individual filling this role will report to the POC Quality Systems Project Manager and is expected to apply problem solving, project management and interpersonal skills to drive results as given to the end goal.
Major Job Responsibilities:
• Lead the Design History File Remediation Project team.
• Train users on new systems and processes.
• Coordinate routing, tracking, and archiving of project documentation.
• Be the Liaison between the project grounds and the stake holders.
• Support the POC Document Control processes within the Edgewater location.
• Work with Cross-functional teams to investigate and resolve complex legacy discrepancies.
• Provide subject matter expertise in determining project methodology and resource allocation confined by QT.
• Assist when needed with.
• Querying and reviewing of technical files via the use of multiple documentation management systems.
• Compiling Design Dossiers.
• Archiving of Design History Files (DHF).
• 10% travel
• Direct a team of 3-5 direct reports.
Required Knowledge/Skills, Education, and Experience:
• 2 - 4 years of demonstrated successful project management.
• 4 - 8+ years of experience in a Quality role within an FDA regulated industry.
• Preferably medical device and Diagnostics.
• SAP PLM knowledge is a must.
• Experience with document control.
• Well versed in Design Control and Design Documentation.
• Certifications such as PMI PMP, AAMI Design Control, Six Sigma, ASQ: CQA, CQE, CQT or equivalent are highly desirable.
• Degree in a related discipline or equivalent combination of education and experience.
• Prefer disciplines in English, Technical Writing, Science or Engineering.
• BS Candidates that possess a MS in the related disciplines stated above.
• Holds a certification such as AAMI Design Control, Six Sigma, ASQ: CQA, CQE, CQT or equivalent.
Knowledge and Experience:
• Demonstrates and applies a broad knowledge of field of specialization through successful completion of moderately multifaceted assignments.
• Successfully applies complex knowledge of fundamental concepts, practices, and procedures of particular area of specialization.
• Demonstrates knowledge of organization's business practices and issues.
• Ability to work independently with minimum level of supervision.