About the position
QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.
Responsibilities
- Leads cross functional project teams. Holds regular meetings and holds team members accountable to project goals.
- Responsible for coordinating team activities in accordance with Design Control, New Product Development Guidelines and Risk Management.
- Works with functional areas to estimate expenses and track budget.
- Supervises and supports development of Design and Development Plan, Risk Management Plan and Report, FMEA, Master Validation Plan and other required documentation.
- Trains other employees in new assays and systems.
- Collaborates with key stakeholders (e.g., Sales, Marketing, Technical Support, Regulatory Affairs and Quality Assurance) to ensure changes meet cross-functional needs.
- Attracts, retains and motivates a high caliber team.
- Leads teams that are necessary to complete required changes including: SOP's, training, systems support and development, labeling, processes for product launch in the EU.
- Participates in internal auditing and training systems to ensure compliance with the quality system.
- Perform other work-related duties as assigned.
Requirements
- Bachelor's degree (BS/BA) in a Biological Science, Mechanical, Electrical / Electronic, Biomedical or Systems Engineering.
- Minimum of 7 years of related experience in program management.
- 3 years in a medical device or related field.
- PMP certification required.
- Has demonstrated experience in managing projects.
- Requires strong written and oral communication skills and good analytical skills.
- Knowledge of timeline and budget management, manufacturing design transfer, Risk Management and Design Control.
- General knowledge of R&D, Regulatory, Quality and Operations activities as it relates to development of a medical device.
- Strong knowledge of quality systems in a manufacturing environment.
- Working knowledge of current FDA, IVDD and other regulations.
- Ability to work cohesively with multi-disciplinary scientific working groups.
- Excellent written, verbal and interpersonal skills to influence many diverse internal/external customer groups.
- Must be able to lead, manage and communicate action items and results from and in meetings in a logical fashion.
- Project management experience is required including proficiency with project tools such as GANTT and PERT charts, MS Project and other tools.
- Excellent prioritization, organization and the ability to multitask.
- Experience in QSR (Quality System Regulations) and ISO medical device standards.
- Strong leadership skills and the ability to foster strong interpersonal relationships between groups.
Benefits
- Comprehensive benefits package including medical, dental, vision, life, and disability insurance.
- 401(k) plan.
- Employee assistance program.
- Employee Stock Purchase Plan.
- Paid time off (including sick time).
- Paid Holidays.
