Quality Engineer- Medical Devices- Rochester, NY

The Quality Engineer (Medical Device) will ensure that all products and processes meet established medical device quality standards by overseeing supplier quality, conducting validations, and implementing corrective actions for injection molded and purchased components. They will also develop and maintain quality control systems to support the full product lifecycle in a clean room manufacturing environment.

Client Details

My client is a global manufacturer of advanced plastic components and assemblies for the medical, pharmaceutical, and life sciences industries. They offer end-to-end support across the product lifecycle, including design, clean room manufacturing, and final assembly, with a focus on regulatory compliance and precision engineering.

Their Rochester, NY facility specializes in producing surgical instruments and high-precision injection molded parts, serving as a technical hub within the organization. With a strong engineering culture and a focus on quality, they partner with leading healthcare companies to deliver customized, mission-critical solutions.

Description

The Quality Engineer (Medical Device) will:

• Ensure products and processes comply with established quality standards and regulatory requirements.
• Lead and support supplier quality activities, including audits, performance monitoring, and corrective actions.
• Develop and implement quality control plans, acceptance sampling, and inspection methods for incoming materials.
• Manage validation activities for injection molded components and purchased parts used in regulated processes.
• Investigate and resolve nonconformances, implementing effective root cause analysis and corrective/preventive actions (CAPA).
• Collaborate with cross-functional teams to support product development, transfers, and lifecycle changes.
• Maintain and improve quality systems in compliance with ISO 13485 and other applicable standards.
• Support internal and external audits, including preparation, participation, and follow-up actions.
• Drive continuous improvement initiatives using tools such as Six Sigma, Lean, and risk analysis.
• Review and approve supplier documentation, including PPAPs, FMEAs, and validation protocols.
• Provide quality input for design reviews, process changes, and supplier qualification activities.
• Ensure proper documentation and traceability throughout manufacturing and quality processes.

Profile

The successful applicant will have:

• Bachelor's degree in Engineering, Quality, or a related technical field (or equivalent experience).
• Experience in a regulated industry, preferably medical device, pharmaceutical, or life sciences.
• Strong knowledge of quality systems and standards (e.g., ISO 13485, FDA QSR, GMP).
• Hands-on experience with injection molding processes and validation of molded components.
• Proven background in supplier quality management, including audits and corrective actions.
• Familiarity with risk management tools such as FMEA, control plans, and process validations.
• Experience with CAPA, root cause analysis, and implementation of preventive measures.
• Proficient in quality tools and methodologies, including Six Sigma, Lean, and statistical analysis.
• Ability to interpret engineering drawings, specifications, and inspection criteria.
• Strong communication and collaboration skills across cross-functional teams and suppliers.
• Working knowledge of acceptance sampling plans and inspection techniques.
• Experience supporting internal and external audits and regulatory inspections.

Job Offer

The Quality Engineer (Medical Device) will receive:

• Opportunity to work in a technically advanced, clean room manufacturing environment.
• Competitive salary with 5% annual bonus
• Join a global company with strong industry reputation and long-term stability.
• Collaborate with cross-functional teams on innovative, life-impacting medical technologies.
• Exposure to the full product lifecycle, from concept through validated production.
• Career growth potential within a multinational organization with multiple sites worldwide.
• Competitive compensation package aligned with experience and qualifications.
• Comprehensive benefits, including health, dental, vision, and retirement plans.
• Supportive, engineering-driven culture focused on continuous improvement and quality excellence.
• Involvement in high-visibility projects with major clients in the healthcare industry.
• Access to professional development, training, and certification opportunities.

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.