Project Manager, Quality Projects - Plainsboro, United States - Aztec
Description
Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare.
The Quality System Project Manager is primarily responsible for the direction, coordination, implementation, and completion of Quality System projects as defined in the Quality Management System (QMS) roadmaps.
Project Managers will work closely with cross functional counterparts and Quality Leadership to define, manage and track appropriate project timelines for key Global Quality Functions, working closely with upper management to make sure that the scope and direction of each project is on schedule.
The Quality System Project Manager partners with corporate, division and cross functional leadership (IS and Operations) globally to ensure that quality system projects and initiatives remain on track to schedule and are conducted in a way that meets relevant procedures, projected measurable benefits and external regulations.
SUPERVISION RECEIVED
Reports to the Director, Digitalization.
SUPERVISION EXERCISED
Indirect management of quality and cross functional resources to support project execution.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Works with Quality project leaders, cross functional and cross quality teams to ensure project scope is appropriately identified, documented and understood.
Develops project plan deliverables and manages the budget and resource loading.
Ensures all elements of a project are understood with proactive work to deliver metric-based benefits.
Tracks project progress, escalates obstacles, and identifies risks and mitigations with broader Quality Leadership Team.
Broad knowledge of applicable regulations and standards (e.g. QSR, ISO 13485, MDD) and how to apply the principles, practices, and procedures.
Coordinates with cross functional leaders in teams such as IS, R&D, Regulatory Affairs, and Operations, to ensure product development metrics are met.
Prepare verbal and written reports and/or presentations on project progress to senior Quality Leadership and cross functional steering committees, as appropriate.
Acts as liaison within the acquisition process to develop quality system transition plans and negotiate terms of transition services.Grow our PMO maturity given newly employed tools and systems.
Ability to take a digital idea or concept through Use Case development and vet feasibility and value to the business.
May work with verbal and/or written instructions.Ability and willingness to travel 30%.
All other duties and responsibilities as assigned.
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill and/or ability required for his position.
Education:
Bachelor's degree required, preferably in a scientific or engineering discipline.
5-7 years of experience in effective project management.
Experience in medical product and device industry with strong concentration in QSR and ISO 13485 compliance and quality assurance preferred.
PMP Certification.Change Management Model Certification or strong working knowledge and application.
This role will allow for work remotely if the successful candidate does not reside near an Integra Lifesciences location.
Skills/Knowledge:
Ability to travel domestically and internationally as business required.
Experience with communicating with domestic and international regulatory bodies.
Strong analytical, strategic, decision making, and risk assessment abilities.
Organizational, leadership, change management and interpersonal skills.
Knowledge of EU MDD / MDR, MDSAP, CMDR, PMDA/PAL, APAC Country requirements, LATAM.
Proficient in the following computer software applications: Microsoft Office
Exceptional interpersonal skills.
Strong organizational and communication skills (written and verbal).
Strong level of initiative, even in the face of ambiguity.
TOOLS AND EQUIPMENT USED
Ability to utilize a computer, telephone, fax and copy machine as well as other general office equipment. Strong computer skills are required.
PHYSICAL REQUIREMENTS
The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of position in order to successfully undertake the essential duties and responsibilities of this position.
In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.
While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, type and move throughout the facility.
In an effort to minimize the spread of the coronavirus and to protect our employees, all new hires in the US and Puerto Rico will need to be fully vaccinated for COVID-19 in order to be considered for employment with Integra LifeSciences, unless eligible for an accommodation as provided by law.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law
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EOE including Disability/Protected Veterans
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the
ADA
. If you have difficulty using our online system due to a disability and need an accommodation, please email us at or call us at
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