Quality Manager

Job Description

Job Description

Quality Manager

Location: Naples, Florida

Salary: $90,000 - $110,000 annually

Relocation Assistance: Negotiable for qualified candidates

Position Overview

We are seeking an experienced Quality Manager with a strong background in medical device precision machining and manufacturing to lead and continuously improve our Quality Management System. The ideal candidate will have a minimum of 8 years of quality leadership experience within a highly regulated medical manufacturing environment and possess extensive knowledge of precision-machined components, inspection methodologies, regulatory compliance, and continuous improvement initiatives.

This position will be responsible for overseeing all quality assurance and quality control activities, ensuring compliance with customer, regulatory, and internal requirements while driving a culture of quality throughout the organization.

Key Responsibilities

• Lead and maintain the company's Quality Management System (QMS) in accordance with ISO 13485, FDA, and regulatory requirements.
• Manage incoming, in-process, and final inspection activities for precision-machined medical device components.
• Oversee internal and external audits, customer audits, and regulatory inspections.
• Drive corrective and preventive action (CAPA) initiatives and root cause analysis using tools such as 8D, Fishbone, and 5 Whys.
• Develop, track, and report quality metrics, KPIs, customer complaints, nonconformances, and supplier performance.
• Collaborate closely with Manufacturing, Engineering, Supply Chain, and Operations teams to improve product quality and process capability.
• Lead validation activities including IQ, OQ, PQ, process validation, and inspection method validation.
• Manage supplier quality programs, supplier audits, and incoming material quality initiatives.
• Ensure compliance with GD&T standards and interpretation of complex engineering drawings.
• Utilize statistical analysis and SPC methodologies to identify trends and improve manufacturing performance.
• Mentor and develop quality engineers, inspectors, and technicians.
• Support customer quality requirements for highly regulated medical and orthopedic device manufacturing environments.
• Champion Lean Manufacturing and Continuous Improvement initiatives to reduce defects and improve operational efficiency.

Required Qualifications

• Bachelor's degree in Engineering, Quality, Manufacturing, or related field preferred.
• Minimum of 8 years of Quality Management experience in a medical device precision machining environment .
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, GMP, and medical device quality requirements.
• Experience with CNC-machined components used in orthopedic, spinal, trauma, cardiovascular, or other medical device applications.
• Thorough understanding of GD&T and blueprint interpretation.
• Experience with CMM programming and inspection systems.
• Proficiency with quality tools including CAPA, FMEA, PPAP, SPC, MSA, and DOE.
• Strong leadership, communication, and team development skills.
• Proven track record of successfully managing audits and regulatory inspections.

Preferred Qualifications

• ASQ Certified Quality Manager (CMQ/OE), Certified Quality Engineer (CQE), or equivalent quality certification.
• Experience working with titanium, stainless steel, cobalt chrome, and other medical-grade materials.
• Lean Six Sigma Green Belt or Black Belt certification.
• Experience with orthopedic implant or surgical instrument manufacturing.

What We Offer

• Competitive salary of $90,000 - $110,000 based on experience.
• Negotiable relocation assistance for qualified candidates.
• Comprehensive health, dental, and vision benefits.
• Paid time off and company holidays.
• 401(k) with company match.
• Career growth opportunities within a growing medical manufacturing organization.

If you are a quality leader with a strong medical machining experience and a passion for driving excellence in a regulated manufacturing environment, we encourage you to apply.

Job Type & Location

This is a Permanent position based out of Naples, FL.

Pay and Benefits

The pay range for this position is $90000.00 - $110000.00/yr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Health, Dental, Vision, PTO

Workplace Type

This is a fully onsite position in Naples,FL.

Application Deadline

This position is anticipated to close on Oct 9, 2026.

About Aerotek

Aerotek® Inc. provides staffing and services solutions in manufacturing, logistics, construction, aviation, facilities and maintenance. We provide the expertise, solutions and people required to rise to the challenges of North American industry. Headquartered in Hanover, Md., Aerotek operates a unified network of over 200 offices across North America, supporting more than 18,000 clients each year. Aerotek is an Allegis Group company, the global leader in workforce and business solutions. To learn more, visit: Aerotek.com | 1-888-AEROTEK.

Aerotek offers weekly pay, employee benefits including medical, dental & vision, life insurance, health advocacy and employee assistance programs, a 401(k) plan, and employee discounts.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

San Francisco Fair Chance Ordinance:
Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector:
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):
We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.