Quality Assurance Engineer

The Quality Engineer provides daily support of products, processes, materials, and equipment in order to achieve production goals (i. e., quality, delivery, cost, productivity, and safety).

Is responsible for assuring all requirements are met for the Product Development Process (PDP), Risk Management, Design Controls, Usability Testing, Production Controls, post market product surveillance.

Works independently on highly specialized projects.

Exercises judgment in determining technical objectives of assignments.

Selects methods and techniques to fulfill quality requirements.

May develop or contribute to departmental technical policies and procedures.

Key Responsibilities

• Identify manufacturing process defects by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions.

May be responsible for working with process owner to bound product stops and document release criteria.

• Understand product quality plans, documents and systems by reviewing product specifications, quality specifications, and working with quality systems.

May be responsible for learning risk analyses and FMEAs.

• Monitor systems by becoming familiar with systems applications and critical process steps, and through familiarization with methods used to reduce process variation.
• Become familiar with product/process improvement efforts by understanding current quality metric data and learning the various analysis methods used to enhance sustaining product design and new product development.
• Learn quality tools and training materials by gaining knowledge of prevalent tools used and by reviewing and utilizing available training materials.
• Check and provide support in the execution and investigation of CAPAs, NCs, failure mode investigations, complaints, etc.
• Evaluate new equipment and processes and participate in the transfer of new products.
• Involve in various stages of equipment and process validations: run and/or review and/or approve reports of IQs, OQs and PQs as well as any other documents relating to validation.
• Read and interpret technical drawings, procedures, and protocols.
• Assure that all laboratory equipment is in compliance to perform the analysis activities (calibration, safety, cleanliness).
• Document investigation findings.
• Become a trainer for the e QMS.
• Work with Research and Development to efficiently qualify new components; assist suppliers in creating statistical sampling plans, inspection methodology, and quality procedures for new components.
• Review and develop process validation protocols and reports; support other functional areas during the validation activities.

Qualifications

• In depth familiarity with the FDA, ISO, MDD/MDR and the medical device industry quality requirements associated with product development, design controls, and product risk management.
• Detailed understanding and working knowledge of US and International regulations including 21CFR820, 803, 50, and 11, as well as the Medical Device Directive/Regulation, EN ISO 13485, EN ISO 14971, IEC 60601, and EN 62366.
• Strong communication and presentation skills.
• Fluent in Italian and English.
• Competent with use of Microsoft Office Suite and Minitab Statistical Analysis software (or equivalent).
• Relevant experience in electro‑optical systems development strongly preferred, ideally in medical device industry.
• Hands‑on experience in a laboratory setting with optical tables, detectors, and alignment techniques is an advantage.
• 5‑7+ years of medical device engineering experience preferred.
• BS in Mechanical, Electrical, or Biomedical Engineering.
• MS strongly preferred.
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