Quality Engineer III- Medical Device- Buffalo, NY

The Quality Engineer III will support the Quality Manager by ensuring compliance with FDA and ISO 13485 standards through designing and implementing quality policies, leading audits, supplier management, and continuous improvement projects. They will also collaborate with operations, product development, and customers to maintain high product quality and regulatory adherence in a fast-paced medical device environment at the Buffalo, NY facility.

Client Details

My client is a specialized medical device manufacturer focused on delivering high-quality, precision-engineered products that comply with strict regulatory standards like FDA and ISO 13485. They emphasize innovation and quality throughout the product lifecycle, from development to market launch, ensuring safety and reliability.

Operating as a midsize company, they foster collaboration between engineering, quality, and operations teams to maintain compliance, manage suppliers, and drive continuous improvement using tools like SPC and FMEA. Their culture values technical expertise, proactive problem-solving, and mentorship to support both product excellence and regulatory adherence in a fast-paced environment.

Description

The Quality Engineer III will be responsible for:

• Ensure compliance with FDA Quality System Regulations and ISO 13485 standards, supporting internal and external audits and inspections.
• Lead quality initiatives related to design control, supplier management, and process validation across medical device product lifecycle.
• Provide technical guidance and quality engineering support to product development, operations, and customer inquiries.
• Develop, maintain, and implement quality policies, procedures, inspection methods, and training materials.
• Manage supplier qualification, audits, corrective actions, and ensure alignment of inspection and testing methods.
• Lead continuous improvement projects using tools such as SPC, FMEA, DOE, and process validation techniques.
• Perform measurement system analyses and oversee equipment calibration processes.
• Direct disposition of nonconforming materials and develop processes to assess product quality and reliability.
• Support project management activities, including cross-functional team coordination and timely product launches.
• Mentor and provide technical guidance to junior quality engineers.
• Utilize data analysis software (e.g., Excel, Minitab) to interpret quality metrics and drive decision-making.
• Comply with safety policies and participate in safety training and hazard analysis efforts.

Profile

The successful Quality Engineer III applicant will have:

• 5+ years of quality engineering experience in the medical device or regulated industry.
• Strong knowledge of FDA Quality System Regulations and ISO 13485 standards, with experience supporting audits and inspections.
• 3+ years of project management experience, including leading cross-functional teams.
• Proficiency in quality engineering tools such as SPC, FMEA, DOE, and process validation.
• Experience with supplier qualification, audits, and managing corrective and preventive actions (CAPAs).
• Skilled in developing and implementing inspection methods, measurement system analyses, and calibration processes.
• Ability to analyze and interpret data using software tools like Microsoft Excel and statistical packages (Minitab preferred).
• Familiarity with Lean Manufacturing and Six Sigma methodologies is a plus.
• Quality certifications (e.g., CQE) preferred or equivalent technical knowledge.
• Strong verbal and written communication skills, including training and presentation abilities.
• Ability to work independently and prioritize in a fast-paced, dynamic environment.
• Commitment to safety practices and experience participating in safety programs or hazard analysis

Job Offer

The Quality Engineer III will receive:

• Opportunity to work in a dynamic, fast-paced environment within the medical device industry.
• Engagement with cross-functional teams, supporting product development, operations, and quality assurance.
• Involvement in regulatory compliance activities, including FDA and ISO quality systems.
• Chance to lead continuous improvement initiatives and apply advanced quality engineering tools.
• Professional growth through mentorship, training development, and expanding technical expertise.
• Exposure to project management responsibilities and leadership of quality-related projects.
• Collaborative culture that values innovation, problem-solving, and knowledge sharing.
• Supportive environment emphasizing safety and adherence to best practices.
• Potential for travel to supplier sites or other company locations as needed (up to 10%).

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.