- • Diverse Project Manager role in an innovative business
- • Entrepreneurial working environment with plenty of development opportunities
We are an innovative medical device company that manufactures, distributes and markets high quality, innovative surgical devices – from niche to proprietary to fast moving consumables surgical device instruments – for minimally invasive and open surgery.
We currently have an opportunity for an experienced Project Manager to manager all projects within our Quality Management System and Product Development/Design Control technical files. Based in Carrum Downs, the role will work closely with the Product Development / Design Control, Quality Assurance & Regulatory Affairs teams.
If you are a project manager that can play the lead role in planning, executing, monitoring, controlling and closing projects then this job is for you!
The primary responsibility of this position is to facilitate and execute business critical outcomes via sound project planning and management. This position requires a detailed understanding of the organisation’s Quality Management System, including but not limited to: quality system implementation, project management design controls, validation (design, process, and/or software), risk management, design verification, and post-market activities .
Key Objectives /Outcomes:
- • Fulfil Project Manager Role for a distinct set of stakeholders by serving as project manager for all management identified mission critical outcomes and translating those outcomes /needs into a defined scope of work, and working with relevant stakeholders and Management Team to effectively complete the
- • Implement processes and procedures in conjunction with the Quality Manager throughout various projects to improve general process and conduct analyses to sustain and improve the organisation’s effectiveness in conjunction with the delivery of the overall project/s. Examples include risk planning, analysis, controls, verification and validation, and inspection methods and procedures.
- • Responsible for coaching staff to effectively communicate with stakeholders, meeting stakeholder deadlines, and management expectations.
Roles and Responsibilities
- • Use creative problem solving skills to identify, solve, and/or improve process and project
- • Supporting management and various ad hoc business consultants in the development and implementation of stakeholder objectives and project plans.
- • Work with staff to handle suppliers, laboratories, stakeholder s, and other group members to assist with implementation and effectiveness of project del
- • Work with Product Development / Design Control Manager and stakeholders to generate project plans and critical path plans.
- • Review documents, data, procedures and protocols/reports for relevancy and technical Application of standards (ISO: 13485).
- • Work with Regulatory Affairs Associate and Quality Manager to ensure FDA submissions are successful delivered.
Knowledge, Experience and Expertise:
- • Must be able to quickly learn and demonstrate competence in the medical device quality systems and standards, regulations and ISO 13485 as well 21CFR820 as required.
- • Able to apply project management techniques in conjunction with the Quality Management System(inclusive of design controls , quality system auditing, inspection methods, statistical sampling plans, gauging studies, design verification and validation , and process validation).
- • Ability to apply theoretical project management skills to real life project outcome
- • Ability to apply logic creativity, and scientific thinking to a wide range of intellectual and practical problems on a daily basis.
- • Ability to manage own time and work independently without excessive overs
- • Professional, firm, clear and calm verbal and written communication skills in working with key internal stakeholder
- • Demonstrates ownership p for the integrity of wor
- • Able to work independently and self-diagnose options for in terms of day to day activities ,
- • Reprioritising and problem solving in order to advance
- • Effective management of projects.
- • Communication and negotiation.
- • Understanding of a multi-faceted business operation.
- • Planning and forecasting.
- • In depth knowledge of business operations and changing business environments.
- • Complex problem solving exposure.
- • Effective decision-making skills.
- • Managing change.
- • Leadership by action.
- • Self -Diagnosing.
- • Proficient in Microsoft Project.
- • Strong ability to manage people and mold to different personalities, getting the best out of staff.
- • Thorough understanding of Medical Device Industry is desirable.
- • Thorough understanding of ISO: 13485 and Regulatory is desirable.
- • Thorough understanding of managing projects is essential.
- • Significant experience in medical device industry and Quality Management System standards and meeting regulatory requirements is desirable.
- • Experience of building a project plans and project management.
- • Significant experience in product development and risk management.
Key Work/ Behavioral Competencies:
- • Strong influencing and relationship management skills.
- • Demonstrated flexibility, including an ability to respond quickly and decisively to the changing requirements.
- • Adaptability, including the ability to learn quickly and proactively initiate action in a dynamic environment.
- • Problem solving, ensuring that all key stakeholders are part of the
- • Strategic and analytical thinker, with a can do, must do
- • Strong customer
- • Proven organisational, prioritisation and planning
Professional / Tertiary Qualifications:
Tertiary degree in appropriate field and or equivalent qualification or suitable experience in a similar roles.
Please email your resume and cover letter to firstname.lastname@example.org to apply.