Global Quality and Regulatory Project Manager

Smiths Medical • Minneapolis, MN 55401

Posted 1 week ago

Job Description

Duties and Responsibilities
  • Report out to sr. leadership on a regular basis project status, action items, issues, and risks, and any need for additional support.
  • Create and maintain comprehensive project artifacts and documentation.
  • Establish and maintain relationships with third parties/vendors as needed.
  • Ensure risk management tools (i.e. FMEA) and techniques are utilized to minimize project risks.
  • Successfully manage the relationship with the client and all stakeholders.
  • Report and escalate to management any issues and/or risks as needed.
  • Track project related costs, and ensure project is proceeding according to approved and predetermined budget.
  • Measure project performance using appropriate tools and techniques.
  • Manage changes to project scope, project schedule, project deliverables, and project costs using the appropriate tracking tools and techniques.
  • Develop a detailed program/project plan to monitor and track overall project progress.
  • Ensure the necessary project resources are allocated, and made available as required.
  • Assist in the development and final definition of project scope, and project objectives, involving all relevant stakeholders and customers, and also ensuring the technical and business feasibility of the proposed project.
  • Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.
  • This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site).
Required Skills and Experience

Educational Requirements:

  • Bachelors Degree is required, technical discipline is preferred. Masters degree is preferred.

Technical Knowledge and Skills:

  • Strong working knowledge of Microsoft Office and Microsoft Project. Use of various PMI tools.
  • Certification: PMP is required. ASQ is a strong plus.
  • Participated in Quality Management System Internal Audit Program a big plus.
  • Experience: At least ten (10) years working in the Medical Device/Pharmaceutical industry. A working knowledge of Good Manufacturing Processes (GMPs) and the Quality System Regulation (QSR) - Part 820. Experience working in, or previously supported, various Quality Assurance, Quality Systems, and Regulatory organizations.
  • Solid organizational skills including attention to detail and multi-tasking skills.
  • Excellent documentation skills. (can create QMS Standard Operating Procedures)
  • Excellent internal communication skills and presentation skills.
  • Solid technical background with understanding and/or hands-on experience of various software systems.
  • Proven working experience and success in project management in the medical device industry.
  • Excellent documentation skills. (can create QMS Standard Operating Procedures)
  • Excellent internal communication skills and presentation skills.
  • Solid technical background with understanding and/or hands-on experience of various software systems.
  • Proven working experience and success in project management in the medical device industry.

Abilities:

  • The role may require domestic and international travel (< 20%).
  • Ability to take on a variety of tasks and pay close attention to detail.
  • Able to provide technical presentations to internal and external audiences.
  • Ability to handle and work effectively under pressure and time constraints.
  • Demonstrated ability to coordinate and lead interdepartmental project team activities in an effective and efficient manner, requiring strong organizational, motivational, and interpersonal skills.
  • Ability to plan and conduct effective meetings and group presentations.
  • Ability to lead and guide project team members in project trouble shooting and carrying out project phases
  • Ability to clearly convey ideas and concepts verbally and in writing.
  • Able to handle multiple priorities and projects and to meet key deadlines under pressure through effective planning and time management.
  • Ability to critically review and interpret technical documentation.
  • Able to apply considerable judgement in the planning, scheduling and coordinating of project phases and schedules.
  • Ability to lead multi- disciplinary projects of significant scope and impact.
  • Advanced problem solving and analytical ability with strong attention to detail.
  • Proven ability to create, lead, establish, maintain and influence effective working relationships with internal and external customers.
  • Demonstrated ability to work with integrity and build trust both inside and outside the Project Team.
About Us

At Smiths Medical, we are passionate about improving and saving the lives of patients through high quality, innovative medical devices and services. We are a leading global manufacturer of specialty medical devices that provides innovative and lifesaving solutions for the worlds healthcare markets.

Specializing in Infusion Therapy, Vascular Access, Vital Care, and Specialty Products & Services, our products are found in hospital, emergency, home and specialty care environments and are used during critical and intensive care, surgery, post-operative care and for supporting managing chronic illness.

Smiths Medical is an EEO/AA Employer/Vet/Disabled

If you require assistance with our online job submission process, please contact our Talent Acquisition team at 855-754-5032 to request an accommodation. Additionally, Smiths Medical invites interested deaf and hard of hearing applicants to use Video Relay Service (VRS).


 

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