Quality Control Engineer

Job Description

Job Description

Job Title: Quality Control Engineer
Company: Medical Device Company
Location: Miami, Florida

Position Overview:
We are seeking a highly skilled and detail-oriented Quality Control Engineer to join our team. The individual in this role will be responsible for ensuring the quality and regulatory compliance of our products, particularly in relation to FDA 510(k) submissions and ISO 13485 standards. The ideal candidate will have experience working in a regulated environment, with strong expertise in managing external consultants, laboratories, and vendors to ensure the highest standards of product quality.

Key Responsibilities:

• Manage 510(k) Consultants : Oversee and collaborate with consultants to ensure timely and accurate submission of FDA 510(k) premarket notifications for veterinary medical devices.
• ISO 13485 Compliance : Ensure full compliance with ISO 13485 standards, including maintaining and updating quality management system documentation, conducting internal audits, and supporting external audits.
• Define Product Test Protocols : Develop and refine test protocols for new and existing products, ensuring they meet regulatory and quality standards.
• Inspection Services & Lab Management : Manage relationships with third-party inspection services and laboratories, ensuring all tests are conducted to required standards and within specified timelines.
• Vendor Quality Management : Maintain and enforce stringent quality standards with vendors and suppliers, working to identify and resolve any quality issues.
• Customer, Vendor, and End-User Interface : Serve as the primary point of contact for quality-related inquiries from customers, vendors, and end-users, providing technical support and resolving any product-related issues.
• Continuous Improvement : Implement continuous quality improvement initiatives to enhance product reliability, safety, and customer satisfaction.

Qualifications: ​​​​​​

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• Proven experience in quality control, quality assurance, or regulatory compliance, preferably in the medical device or veterinary products industry.
• Self-starter with the ability to work independently, take initiative, and complete projects with minimal supervision.
• Strong knowledge of FDA 510(k) submission processes and ISO 13485 standards.
• Experience managing external consultants, third-party inspection services, and laboratories.
• Excellent organizational and project management skills with the ability to prioritize and manage multiple tasks.
• Strong communication skills to interface effectively with customers, vendors, and internal stakeholders.
• Analytical mindset with problem-solving skills and attention to detail.
• Ability to collaborate and work well within a team, while being tactful and professional in all interactions.

Preferred Skills:

• Familiarity with veterinary medical devices and hospital supplies.
• Certification in quality management or regulatory affairs (510K, ISO 13485, QMS) is a plus.

How to Apply:
Interested candidates are encouraged to submit their resume and cover letter detailing their relevant experience through Zip Recruiter. We are an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Pay will be commensurate with skills, abilities and expected impact.

We are a well-established brand and private label supplier of quality veterinary products working with some of the industry’s largest distributors. We provide a healthy work environment, competitive salaries and attractive working hours; making our company an amazing place to work and grow.

Company Description

We are a well-established brand and private label supplier of quality veterinary products working with some of the industry’s largest distributors. We provide a healthy work environment, competitive salaries and attractive working hours; making our company an amazing place to work and grow.