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).

Interview Process: Phone screen and then either onsite or teams meeting for 2nd interview depending on if candidate is local or not.

Note: Open to non-local candidates who are willing to relocate at own expense. Overtime highly likely.

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.