Quality Engineer (Visa Sponsorship Assistance Not Available)

Millstone Medical Outsourcing is looking to hire a highly skilled and motivated Quality Engineer to join our team at Millstone Medical Outsourcing.

"Candidates must be located in or near Olive Branch, MS for regular onsite work. Relocation assistance is not available. "

The Quality Engineer will be responsible for ensuring the highest quality standards in a fast-paced work environment. The role focuses on metrology, GD&T, CAPA, validation, and continuous improvement initiatives. Additionally, the position will involve procedure writing, training, customer liaison, and complaint handling to ensure regulatory compliance and customer satisfaction.

This position will assist in performing the essential duties and responsibilities listed below ensuring that customer and internal requirements are met while meeting the requirements of the company's Quality Policy, established Quality Objectives, as well as regulatory requirements as outlined in ISO13485, FDA 21 CFR Part 820 & 1271.

The role of the Quality Engineer is to assist in the planning, executing, and finalizing projects to strict deadlines. Specific functional areas include the creation and maintenance of system procedures & work instructions, support the internal auditing program, as well as data analysis, complaint handling, and CAPA investigations.

- Perform dimensional inspections using a variety of metrology equipment.

- Interpret and apply GD&T principles to product designs and inspection processes.

- Lead the investigation of quality issues, root cause analysis, and implementation of corrective and preventive actions.

- Monitor and document CAPA activities to ensure timely closure and compliance with regulatory standards.

- Support validation activities for equipment, processes, and software (IQ, OQ, PQ) in compliance with regulatory requirements.

- Develop validation protocols and reports, ensuring that systems meet defined specifications.

- Develop and deliver training on quality standards, procedures, and best practices to the team and operators.

- Ensure training compliance for quality-related processes and systems.

- Lead and participate in continuous improvement initiatives (Lean, Six Sigma) to enhance product quality and process efficiency.

- Identify opportunities to improve processes and reduce defects.

- Investigate customer complaints, perform root cause analysis, and implement corrective actions.

- Communicate findings and resolutions to customers, ensuring transparency and building customer trust.

- Serve as a point of contact for quality-related discussions with customers.

- Collaborate with customers to resolve quality issues and ensure their requirements are met.

- Provide support during customer audits and quality assessments.

- Ensure compliance with relevant regulatory standards, such as ISO 13485, FDA 21 CFR Part 820, and EU MDR.

- Maintain accurate and thorough documentation to meet regulatory and customer requirements.

- Develop, review, and update quality system procedures, work instructions, and inspection criteria.

- Ensure all documentation is aligned with industry regulations and best practices.

- 3-5 years of experience in the medical device industry, with a focus on quality assurance.

- Strong knowledge and understanding of metrology, CAPA, GD&T, experience interpreting engineering drawings and validation processes.

- Six Sigma Green/Black Belt or ASQ Quality Engineer certification is a plus.

- Proficient in the use of metrology equipment and software.

- Knowledge of quality management systems (QMS) and regulatory standards.

- Superior written and strong communication skills for liaising with customers and cross-functional teams.

Qualifications: Must have a Bachelor's degree in Engineering.