Manager Quality Compliance

Meet the team

Our Quality organization is at the heart of everything we do. We are a collaborative, mission‑driven team committed to ensuring that every device we bring to market is safe, effective, and meets the highest standards of regulatory compliance. As part of the Quality Assurance (QA) Team, you’ll join a diverse group of professionals who work cross‑functionally with Engineering, Supply Chain, and Operations to uphold our commitment to patient safety and product excellence.

We work closely with teams across the company to support design controls, validation activities, CAPA management, supplier quality, and product lifecycle initiatives while keeping focus on producing high quality product for our patients. We believe quality is everyone’s responsibility—and we lead by example.

• You will oversee the site Document Control team who are responsible for overseeing the creation, review, approval, and maintenance of controlled documents within the Quality Management System (QMS).
• You will be responsible for ensuring compliance with ISO 13485, FDA, and other applicable regulatory standards. You will monitor QMS performance metrics and drive continuous improvement initiatives. You will facilitate internal/external audits within the organization.
• You will support regulatory submissions related to complaints, submissions and change notifications to notified body. Lead cross‑functional discussions to identify and address site needs, ensuring operations remain aligned with the facility's approved scope of work and compliance obligations.
• You will lead remediation activities related to quality system gaps, observations, and compliance risks and ensure a state of audit readiness across all quality system processes.
• You will be responsible for developing and reporting compliance metrics to site leadership, analyze quality trends and identify emerging compliance risks. You will present quality system performance during management reviews and business reviews.
• You will be responsible for the site Internal Audit program by developing annual and multi‑year audit schedules based on regulatory requirements, risk assessments, prior audit findings, and quality system performance.
• You will ensure compliance to in‑house and external specifications and standards. Provide guidance on NCMR dispositions and investigations and guidance on the CAPAs.
• You will develop, manage, and facilitate site‑wide Quality, CAPA, and MRB governance forums to ensure the efficient escalation, investigation, documentation, and resolution of quality issues while driving compliance, accountability, and continuous improvement.
• You will manage a team of Quality Assurance personnel of varying levels.

• You will have knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO 13485 Quality Management Systems).
• You will be able to organize and prioritize assignments providing direction to and participation in assigned functional teams.
• You are able to foster strong working relationships across all organizational levels to champion quality excellence and ensure product quality and patient safety remain at the forefront of all decisions.
• You will have technical writing skills as applied to quality and manufacturing documentation and process development – Experience in creating and revising technical documentation.
• You have the ability to deal with ambiguity/uncertainty and a willingness to try new/challenging things with a proven track record of working hands‑on in a fast‑paced environment.
• You can use analytical tools (5 Whys, fishbone, FMEA, DOE) to make clear, defensible decisions using risk‑based methodology that balances…