What are the responsibilities and job description for the Quality Project Manager position at Indotronix International Corp?
Job Details
Title: Quality Project Manager
Location: Oneonta, NY, 13820
Duration: 7 Months Contract
Pay rate: $42/hr W2
Summary:
This facility is undergoing a Quality System Transformation from ISO 9001 to ISO 13485. Looking for minimum of 2 years Project Management experience with managing this type of transition. ETQ experience on top of this will set a candidate apart from others. Bachelors required (though manager would consider additional years experience or accreditations in lieu of Bachelors).
Job Description:
- Seeking an experienced Quality Project Manager to lead and manage quality management system (QMS) transformation projects within our organization.
- The successful candidate will have a strong background in project management at a systems transformation level and extensive experience transitioning QMS from ISO 9001 to ISO 13485.
- This role requires a detail-oriented and proactive individual who can effectively manage complex projects and ensure compliance with regulatory standards.
Education and Experience Required:
- Bachelor s degree in Quality Management, Engineering, Life Sciences, or a related field.
- Minimum 2 years of experience in quality management and project management roles within a regulated industry.
- Proven project management experience at a systems transformation level.
- Demonstrated experience in transitioning QMS from ISO 9001 to ISO 13485 with a preference for candidates who have led such projects.
- Regulatory experience in an ISO 13485 or ISO 15378 environment.
- Strong understanding of quality management principles and best practices.
- Excellent leadership, communication, and interpersonal skills.
- Ability to manage multiple projects and priorities in a fast-paced environment.
- Strong problem-solving skills and attention to detail.
- Project Management Professional (PMP) certification or equivalent is a plus.
Key Responsibilities:
- Lead and manage projects focused on transforming and transitioning quality management systems from ISO 9001 to ISO 13485.
- Develop comprehensive project plans, including timelines, resource allocation, and risk management strategies.
- Coordinate and collaborate with cross-functional teams to ensure successful project execution and alignment with strategic goals.
- Ensure compliance with ISO 13485 standards and regulatory requirements throughout the project lifecycle.
- Conduct regular project reviews to assess progress, identify any issues or risks, and implement corrective actions as necessary.
- Provide expertise and guidance on regulatory requirements and standards applicable to ISO 13485 environments.
- Facilitate communication and reporting to stakeholders, ensuring transparency and alignment with project objectives.
- Drive continuous improvement initiatives to enhance quality processes and systems.
Salary : $42 - $43