We are seeking a collaborative, hands-on Quality Assurance & Quality Control Manager to lead our site Quality organization in beautiful Bonita Spring to drive a culture of operational excellence, continuous improvement, and regulatory compliance. This role is responsible for ensuring our Quality Management System meets the highest standards while partnering closely with Operations, Engineering, Supply Chain, and Regulatory Affairs to deliver exceptional quality, customer satisfaction, and business performance.

The ideal candidate is a visible leader who thrives in a fast-paced manufacturing environment, builds high-performing teams, and balances uncompromising quality standards with a practical, solutions-oriented approach. If you are passionate about developing people, strengthening quality systems, and driving continuous improvement in an FDA-regulated, ISO 13485-certified medical device environment, we invite you to join us as we continue to grow and transform our business.

1. Job Duties and Tasks

1. Quality Assurance

1.1.1 Act as the designated Management Representative, ensuring the QMS meets regulatory and customer

Requirements.

1.1.2 Lead Management Reviews and communicate QMS performance to top management.

1.1.3 Lead and coordinate internal audits to ensure compliance with QMS requirements.

1.1.4 Serve as the primary liaison for external audits, including regulatory inspections, certification body

audits, and customer audits.

1.1.5 Oversee and maintain compliance with ISO 13485, 21 CFR 820, and other applicable standards and

regulations.

1.1.6 Identify and drive continuous improvement initiatives within the QMS

1.1.7 Manage the complaint handling process, ensuring timely investigation, root cause analysis, and

resolution in compliance with applicable regulations.

1.1.8 Manage the CAPA system to ensure timely identification, investigation, and resolution of issues.

1.1.9 Oversee the nonconformance program to ensure proper documentation, investigation, and resolution.

1.1.10 Oversee supplier evaluation, approval, and monitoring processes to ensure supplier quality.

1.1.11 Ensure that equipment calibration and preventive maintenance schedules are implemented and

adherence to in compliance with regulatory requirements.

1.1.12 Develop and update quality policies, procedures, and work instructions as necessary.

1.1.13 Monitor and report key quality metrics to management, driving accountability and improvement.

1. Stay updated on regulatory changes and ensure the QMS reflects the latest requirements.

1.2 Quality Control

1.2.1 Manage lab operations to ensure timely and efficient inspection and release of products.

1.2.2 Prioritize workflow to meet production and customer requirements.

1.2.3 Ensure quality inspectors perform inspections according to established procedures and protocols

1.2.4 Regularly review inspection records and result to ensure accuracy and compliance.

1.2.5 Oversee the final product release process, ensuring all inspections and documentation are completed

and compliant.

1. Key Skills, Knowledge and Competencies:

2.1 Minimum 10 years of experience in quality assurance/control within the medical device industry.

2.2 Proven experience with ISO 13485:2016, 21 CFR 820, and FDA regulatory requirements

2.3 Experience in leading audits, CAPA management, and supplier quality management

2.4 Strong leadership and team management skills

2.5 In depth knowledge of QMS and regulatory standards for medical devices

2.6 Excellent problem-solving and analytical skills

2.7 Effective communication and interpersonal skills for collaboration with internal and external

stakeholders

2.8 Must have superior decision-making skills, problem solving skills and conflict management abilities.

2.9 Ability to read and understand blueprints and GD&T requirements from customer specifications.

1. Education, Certifications, And/or Licenses Requirements:

Bachelor's or equivalent in Engineering, Quality Management or related field