Quality Systems Manager

About the role:

We are looking for an experienced and motivated Quality Systems Manager to play a key role in strengthening our culture of quality and continuous improvement. In this role, you will ensure compliance with regulatory standards (including FDA and ISO 13485) and alignment with industry best practices. While we are currently ISO 9001 certified, we are actively pursuing ISO 13485 certification, and this position will be instrumental in that journey.

The ideal candidate is a flexible, adaptive leader and proactive self-starter who brings strong communication skills, a collaborative approach, resilience, and a positive outlook.

What you will be doing:

Quality Management System (QMS) Oversight

• Develop, maintain, and improve the QMS to ensure compliance with internal policies and external regulations.
• Regularly review quality processes and documentation for opportunities to optimize or enhance.
• Lead cross-functional initiatives to drive continuous improvement using Lean, Six Sigma, and other methodologies.

Document Control (Doc Ctrl) Oversight

• Manage the Document Control program, ensuring all controlled documents (SOPs, WIs, forms, records, etc.) are accurate, current, securely maintained, and distributed in accordance with quality and regulatory requirements.
• Oversee the end-to-end ECO process, ensuring proposed changes (to products, manufacturing, or documentation) are evaluated, approved, implemented, and documented in a compliant and timely manner.
• Collaborate with stakeholders across R&D, and Manufacturing to assess change impact and risk.
• Ensure robust lifecycle management: creation, review, approval, revision, obsolescence, and archival of documents.

Audit Leadership

• Prepare for and lead internal and external audits, coordinating timely responses and implementing effective corrective actions for all findings.

Training & Quality Culture

• Design and deliver training programs on QMS, continuous improvement, ECO, and document control processes.
• Instill a quality mindset at all levels of the organization.

Metrics & Management Reporting

• Track, analyze, and report on quality, ECO, and document control metrics to guide decisions and support senior management.

Minimum Requirements:

• Bachelor's degree in Life Sciences, Engineering, or a related field.
• Minimum of 3-5 years of management experience in the life sciences or medical device industry.
• Strong background managing a QMS and working with ECO/change control and document control systems.
• Working knowledge of regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, ISO 9001).
• Experience optimizing Document Control practices and supporting validation of electronic document management systems.
• Demonstrated success leading continuous improvement projects (Lean/Six Sigma certification is a plus).

Preferred Skills and Attributes:

• Strong organization, project management, and analytical skills.
• Excellent communication and influencing abilities at all organizational levels.
• Detail-oriented, proactive, and passionate about quality and compliance.
• Ability to work independently and as part of a team.
• Proactive and able to identify and solve problems effectively.
• Curious to learn and try new things and develop new skills.
• High level of integrity and professionalism.

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