Senior Quality Engineer - Plastics Injection Molding

Job Description

Job Description

Crafting Precision, Powering Progress

Job Opportunity at American Tool & Mold : Join the Team that Builds America

Are you passionate about precision, innovation, and the craftsmanship behind the tools that power America's industries?

At American Tool & Mold, we're more than a manufacturing company - we're a dedicated team shaping the future with precision and reliability.

Job Summary : Senior Quality Engineer FDA / ISO13485

The Senior Quality Engineer will provide experienced quality assurance support to the product development team, document and submit 510K to FDA, Lead CAR resolving of defects and ensuring the product meets customer specifications and regulatory requirements.

Supervisory Responsibilities :

• May assist with hiring quality technicians.
• Mentors and trains quality technicians and inspectors on policies and procedures.
• May assist with performance evaluations.

Essential Responsibilities :

• Initiates FDA 510K documentation and successfully submitted to the FDA for approval.
• Performs Internal Audits to ISO-13485 and FDA Regulations.
• Ensures manufacturing processes comply with federal, state, local, and industry standards and regulations.
• Reviews design plans, process procedures, test procedures, and quality manuals to understand the scope, requirements, and function of the problem.
• Ensures that products meet the organization and customers’ quality and product integrity requirements.
• Supports the product development or operations team by providing analysis and expertise throughout the inspection process.
• Identifies root causes of problems in the production process; recommends and / or implements corrective actions.
• Analyzes data to identify trends in product quality or defects with a goal of mitigating and preventing recurrence and future defects.

Required Skills / Abilities :

• Excellent organizational skills and attention to detail.
• Extensive knowledge of or the ability to quickly learn production processes.
• Excellent interpersonal skills with the ability to serve as a liaison with developers, project managers, and customer support.
• Thorough understanding of federal, state, local, and industry standards, guidelines, and regulations.
• Strong analytical and problem-solving skills.
• Proficient with Microsoft Office Suite or related software.
• Self-starter and motivated individual

Education and Experience :

• At least five years of related experience in FDA / ISO-13485
• Bachelor’s degree in Engineering or related discipline not required but strongly recommended.
• ASQ SQE and SQA Certification - preferred

Physical Requirements :

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift 15 pounds at times.

Travel Requirements :

Travel could be 15%.

We offer a competitive compensation and benefits package, including health, dental, vision, life, ADD, LTD, STD insurance, a 401(k) plan with company match, and a robust professional development program.

At American Tool & Mold, our employees are the heart of our company. We value hard work, dedication, and the endless pursuit of perfection.

We believe in nurturing the talent of our team members, providing opportunities for growth and development.

Don't miss out on this chance to join a company that's not just manufacturing tools but crafting the backbone of American industry.

Apply today and help us "Craft Precision, Power Progress."

American Tool & Mold is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.