Top 13 Quality assurance manager Jobs in Bonita Springs Fl

Senior Manager, Quality Systems
Arthrex —Naples, FL
- Basic math
- Office
- 8 years
- Paid parental leave
- Health insurance
Quality Manager OTC Skincare and Feminine Hygiene
Medical Group Care —Naples, FL
- $120,000 - $130,000 a year
- Full-time
- 5 years
- Mid-level
- Bachelor's degree
Quick Apply
Manager Obstetrics Quality
Lee Health —Fort Myers, FL
- $38.48 - $50.01 an hour
- Full-time
- Nursing
- Microsoft Excel
- Microsoft Access
7d
Water Quality Project Manager
City of Naples, FL —Naples, FL
- $90,402 - $140,123 a year
- Full-time
- Microsoft Outlook
- Construction site
- 5 years
Manager, Supplier Quality (Sustaining and Development)
Arthrex —Naples, FL
- Up to 50% travel
- Basic math
- Office
- Paid parental leave
- Health insurance
Quality & Food Safety Manager
Gelatys —Fort Myers, FL
- $65,000 - $70,000 a year
- Full-time
- Spanish
- Management
- 5 years
- Paid time off
Quick Apply
2d
Contractor Quality Assurance/Control Supervisor - Landfill Construction/Cap Construction
Ayuda Companies —United States
- $90,000 - $120,000 a year
- Full-time
- Background check
- Construction site
- Pass drug screening
- Disability insurance
- Health insurance
Quick Apply
Quality Control Manager- Dam Project
Thalle Construction Company —United States
- Full-time
- Construction site
- Senior level
- Professional Engineer
- Paid holidays
- Disability insurance
Quick Apply
11d

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quality assurance manager jobs near bonita springs fl

Senior Manager, Quality Systems

Arthrex -
Naples, FL

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Job Details

Benefits

Paid parental leave
Health insurance
Dental insurance
Flexible spending account
Tuition reimbursement
Paid time off
Parental leave
Employee assistance program
401(k) matching
Life insurance
Food provided

Qualifications

Regulatory inspections
Managerial strategic planning
Team leadership
ISO standards
Quality control audit
Team development
Medical device manufacturing facility experience
Data-driven problem-solving
Biomedical regulatory compliance
Cross-functional collaboration
Cross-functional communication
FDA regulations
Senior leadership

Full Job Description

Requisition ID:

66359

Title:

Senior Manager, Quality Systems

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Senior Manager, Quality Management Systems for our global headquarters in Naples, Florida. The Senior Manager, Quality Management Systems is responsible for leading, maintaining, and continuously improving the Arthrex Quality Management System (QMS) to ensure compliance with global regulatory requirements including FDA 21 CFR Part 820, ISO 13485, and other applicable standards. This role drives quality system effectiveness across core processes such as CAPA, change management, audits, document control, and training, while supporting inspection readiness and enabling business growth. This position requires a strategic leader who can balance compliance with operational efficiency, foster cross-functional collaboration, and elevate quality systems as a proactive enabler of organizational excellence. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Duties and Responsibilities:

Quality System Leadership

Lead and oversee the end-to-end QMS, ensuring compliance with FDA, ISO 13485, and global regulatory requirements

Establish and drive quality strategy, governance, and system performance metrics

Ensure alignment and scalability of quality systems across sites and functions

Core QMS Process Ownership

Provides oversight of critical quality system elements:

CAPA (Corrective and Preventive Actions)

Nonconformance (NCR) management

Document Management / Change control

Document and record control

Training and competency systems

Drive continuous improvement initiatives to enhance system effectiveness and reduce risk

Audit & Inspection Readiness

Lead and develop risk-based internal audit program and schedules

Ensure ongoing inspection readiness and lead FDA, notified body, and other regulatory inspections

Partner with site leadership to address audit findings and drive sustainable corrective actions

Compliance & Risk Management

Implement risk-based approaches to quality system monitoring and decision-making

Ensure timely identification, escalation, and resolution of compliance gaps

Monitor regulatory changes and drive system updates accordingly

Metrics & Continuous Improvement

Establish and monitor KPIs for QMS effectiveness (e.g., CAPA cycle time, audit trends, training compliance)

Leverage data analytics to identify trends, systemic issues, and improvement opportunities

Coordinate and support all QMS Management Review activities.

People Leadership

Lead, develop, and mentor a team of quality professionals

Build a culture of ownership, accountability, and continuous improvement

Drive capability development in auditing, compliance, and quality system processes

Education and Experience:

Bachelor’s degree required, preferably in an Engineering or Science discipline
15 years related experience required in a medical device or similar regulated environment
8 years of quality leadership experience required
Experience with global/multi-site quality systems
Experience supporting FDA or notified body inspections

Knowledge and Skill Requirements/Specialized Courses and/or Training:

Strong working knowledge of FDA QSMR, ISO 13485 and applicable international regulations.
Proven experience leading audits and regulatory inspections
Strong leadership and people development skills
Ability to influence cross-functional stakeholders at all levels
Strategic thinker with strong execution and problem-solving capabilities
Experience driving system improvements and transformation initiatives

Machine, Tools, and/or Equipment Skills:

Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), PowerPoint, SAP or similar business software.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Mathematical Skills

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.

Language and Communication Skills:

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.

Arthrex Benefits

Medical, Dental and Vision Insurance
Company-Provided Life Insurance
Voluntary Life Insurance
Flexible Spending Account (FSA)
Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
Matching 401(k) Retirement Plan
Annual Bonus
Wellness Incentive Program
Free Onsite Medical Clinics
Free Onsite Lunch
Tuition Reimbursement Program
Trip of a Lifetime
Paid Parental Leave
Paid Time Off
Volunteer PTO
Employee Assistance Provider (EAP)
Eligible for discretionary Long Term Incentive program

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.

Apply Now

Refine Your Search

quality assurance manager jobs in bonita springs fl

Senior Manager, Quality Systems

Quality Manager OTC Skincare and Feminine Hygiene

Manager Obstetrics Quality

Water Quality Project Manager

Manager, Supplier Quality (Sustaining and Development)

Quality & Food Safety Manager

Contractor Quality Assurance/Control Supervisor - Landfill Construction/Cap Construction

Quality Control Manager- Dam Project

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