Job Description
Job Description
Quality Engineer – Onsite (Savannah, GA)
Overview
This position is responsible for developing, implementing, and maintaining systems to ensure products and services meet or exceed customer expectations and comply with applicable regulatory requirements, including FDA, Health Canada, European MDD / MDR, and other global standards. The role also supports quality system processes such as complaint handling, process validation, nonconformities, product development, and supplier quality.
Key Responsibilities
- Support continuous improvement by identifying opportunities in product design and manufacturing processes.
- Provide quality engineering expertise throughout the product lifecycle, including risk management, design changes, and CAPA investigations.
- Author, review, and approve quality system documentation, material review board product dispositions, and engineering change controls.
- Partner with suppliers and manufacturing teams to improve quality, reduce defects, and enhance yield; participate in supplier qualification and selection.
- Perform trend analysis and business impact assessments on product and process data to identify and address quality issues.
- Provide quality input and guidance during product development and improvement projects; validate design inputs for performance, reliability, manufacturability, and safety.
- Plan, control, and assure product and process quality in accordance with quality principles and best practices, including process validation, sampling, and measurement systems.
- Author and execute validation, verification, and inspection assessments to ensure data supports product release.
- Maintain up-to-date knowledge of relevant global quality and regulatory standards, implementing changes as needed.
- Conduct computer system validation activities and ensure compliance with current validation requirements.
- Participate in special projects and other assigned duties.
Qualifications
Experience :
3+ years of engineering experience, ideally in the medical device industry, with exposure to product development or manufacturing engineering.Demonstrated experience in a regulated, disciplined engineering environment.Education :
Bachelor’s degree in engineering (mechanical or electrical preferred).Advanced degree or ASQ certification a plus.Skills & Competencies
Strong knowledge of medical device regulations (21 CFR 820, MDD, MDR) and quality system standards (ISO 13485, ISO 14971, IEC 60601).Proficiency in root cause analysis, CAPA, risk management, process validation, and verification testing.Working knowledge of LEAN and Six Sigma methodologies.Strong analytical, problem-solving, and decision-making skills.Excellent verbal and written communication; capable of presenting effectively to management.Strong project management, planning, and organizational skills.Ability to manage supplier quality and drive continuous improvement.Familiarity with computer system validation and related regulatory expectations.Company Description
Marquee Staffing has built a reputation on expert local market knowledge, unparalleled personalized service and the ability to deliver winning candidates and job opportunities.
Marquee operates offices located conveniently throughout Southern California. Each branch is full-service, providing temporary, contract, contract-to-hire and direct placement services for a diverse set of clients. Each branch has recruiters who specialize in key industries, ensuring that our clients get the best match possible for each open position and that our candidates get expert guidance in their career path.
Apply with us today!
Company Description
Marquee Staffing has built a reputation on expert local market knowledge, unparalleled personalized service and the ability to deliver winning candidates and job opportunities.\r\n\r\nMarquee operates offices located conveniently throughout Southern California. Each branch is full-service, providing temporary, contract, contract-to-hire and direct placement services for a diverse set of clients. Each branch has recruiters who specialize in key industries, ensuring that our clients get the best match possible for each open position and that our candidates get expert guidance in their career path.\r\n\r\nApply with us today!