Quality Engineer - Brasseler

Don’t just work somewhere, join Brasseler and be a valued team member of a world‑class health care organization!

Our Culture:
Provides a safe and welcoming environment where team members can balance their lives and develop their careers. All people and experiences are valued and respected. Different perspectives are encouraged and lead to better results. This makes us who we are and enables us to be a world‑class healthcare organization. All who join us are accountable to this charge.

Our Philosophy:

Quality products sold with integrity has been the hallmark of Brasseler USA from the beginning. Brasseler USA’s strong reputation of providing high quality, clinician endorsed and innovative dental and medical instrumentation nationally has spanned over 40 years. We have been offering a full‑range of products made in the USA since 1976. Many of our products are manufactured at our headquarters in Savannah, GA.

Explore our career opportunities below to learn more.

JOB OVERVIEW:

This position is responsible for developing and implementing systems to ensure products and/or services are design and produced to meet or exceed customer expectations and regulatory requirements including the US Food and Drug Administration, Health Canada, European MDD/MDR and others as required. This role will also participate in the implementation of the company’s quality system processes related to complaint handling, process validation, internal nonconformities, product development and supplier quality to provide engineering analysis and support in verification, validation and problem solving.

KEY RESPONSIBILITIES:

• Engages in continuous improvement activities by identifying opportunities and recommending improvements to product design and manufacturing processes. Provides ongoing quality engineering support throughout the product lifecycle, including risk management, design and manufacturing changes and CAPA investigations.

• Drives supplier quality improvement by providing engineering analysis related to component specifications and root cause analysis. Partners with key suppliers and manufacturing personnel to reduce defects and improve yield. Participates in supplier selection and qualification processes.

• Conduct periodic trend analysis and provides business impact analysis of product and process trends to monitor and take appropriate corrective/preventive actions to ensure product quality, patient safety and compliance with regulatory reporting requirements. Implements problem solving methodologies to reduce internal and external defects.

• Provide quality engineering insight and guidance on product development, product improvement and process improvement projects. Validates key design inputs including usability, reliability, performance, ability to manufacturer, safety and effectiveness.

• Plan, control and assure product and process quality in accordance with quality principles and best practices, including process planning, material control, acceptance sampling, measurement systems and process validation. Identifies and implements product and process controls consistent with the outcome of the risk management process.

• Author validation, verification and inspection assessments to ensure product test and manufacturing data support product release. Select appropriate tests and sampling sizes based on critical abiland statistical calculations.

• Maintains knowledge of relevant quality and regulatory standards and augments quality system processes to meet changing requirements, including the Medical Device Directive, Medical Device Regulation, US FDA, MDSAP and others as required.

• Conduct computer system validation and stay current with validation regulatory requirements.

• Participates in special projects and perform other duties as required.

MINIMUM

WORK EXPERIENCE:

3 or more years of engineering experience, ideally within the medical device industry, including roles within product development or manufacturing engineering. Experience in a disciplined engineering environment.

PREFERRED EDUCATION:

A Bachelor's Degree in engineering, typically electrical or mechanical. Master's degree in engineering, an MBA or global equivalent a plus. ASQ…