Quality Engineer (Visa Sponsorship or Relocation Assistance Not Available)

External applicants•Olive Branch, MS

2d•Onsite

About The Position

Millstone Medical is a fast-growing, fast-paced medical service provider for top Orthopedic companies, specializing in sterile and non-sterile packaging of medical devices. They also perform mechanical inspection and assembly to meet outsourcing requirements of medical device manufacturers. Millstone is FDA and ISO registered and employs a detailed internal quality system to ensure ISO compliance. This role offers opportunities for learning and growth within an employee-centric culture. The Quality Engineer will ensure the highest quality standards, focusing on metrology, GD&T, CAPA, validation, and continuous improvement. Responsibilities include procedure writing, training, customer liaison, and complaint handling to ensure regulatory compliance and customer satisfaction. The position assists in meeting customer and internal requirements, adhering to the company's Quality Policy, Quality Objectives, and regulatory requirements (ISO13485, FDA 21 CFR Part 820 & 1271). The role involves planning, executing, and finalizing projects, creating and maintaining system procedures & work instructions, supporting the internal auditing program, data analysis, complaint handling, and CAPA investigations.

Requirements

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.
Proficient in the use of metrology equipment and software.
Knowledge of quality management systems (QMS) and regulatory standards.
Excellent problem-solving and analytical skills.
Superior written and strong communication skills for liaising with customers and cross-functional teams.
Ability to manage multiple projects and meet deadlines.
Bachelor’s degree in Engineering.

Nice To Haves

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

Responsibilities

Perform dimensional inspections using a variety of metrology equipment and ensure accuracy and traceability of measurement systems.
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, monitoring and documenting CAPA activities.
Support validation activities for equipment, processes, and software (IQ, OQ, PQ) and develop validation protocols and reports.
Develop and deliver training on quality standards, procedures, and best practices.
Lead and participate in continuous improvement initiatives (Lean, Six Sigma) to enhance product quality and process efficiency.
Investigate customer complaints, perform root cause analysis, implement corrective actions, and communicate findings and resolutions to customers.
Serve as a point of contact for quality-related discussions with customers, collaborating to resolve issues and support customer audits.
Ensure compliance with relevant regulatory standards (ISO 13485, FDA 21 CFR Part 820, EU MDR) and maintain accurate documentation.
Develop, review, and update quality system procedures, work instructions, and inspection criteria.