Quality Control Project Manager Manufacturing

Job Description

Description:

Title: Quality Project Manager

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.Company Description

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