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Job Requirements of Quality Project Manager:
-
Employment Type:
Contractor
-
Location:
Oneonta, NY (Onsite)
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Quality Project Manager
Careers Integrated Resources Inc
Oneonta, NY (Onsite)
Contractor
Title: Quality Project Manager
- 100% onsite at the Oneonta Plant, no remote work
- Open to non-local candidates who are willing to relocate at own expense
- Possibility of extension past December, but no guarantee. Assignment may be extended to help with remediation
- Interview process: Phone screen and then either onsite or teams meeting for 2nd interview depending on if candidate is local or not
- Overtime highly likely
Information about this position: 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.
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.
Requested Requirements:
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.
Education and Experience:
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.
- 100% onsite at the Oneonta Plant, no remote work
- Open to non-local candidates who are willing to relocate at own expense
- Possibility of extension past December, but no guarantee. Assignment may be extended to help with remediation
- Interview process: Phone screen and then either onsite or teams meeting for 2nd interview depending on if candidate is local or not
- Overtime highly likely
Information about this position: 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.
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.
Requested Requirements:
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.
Education and Experience:
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.
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