The Quality Assurance 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 (scrap, nonconforming material, customer complaints) 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.Understanding of 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.Monitoring Systems by becoming familiar with systems applications and critical process steps; and through familiarization with methods used to reduce process variation.Becomes 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.Learns Quality Tools & Training Materials by gaining knowledge of prevalent tools used and by reviewing & utilizing available training materials.Checks and provides support in the execution and investigation of CAPAs, NCs, Failure Mode Investigations, Complaints, etc.Evaluates new equipment and processes and participates in the transfer of new products.Get involve in various stages of equipment and processes validations: Run and / or review and / or approve reports I.Q 's, O.Q' s and P.Q 's as well as any other document 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, cleanness).Support Internal/External Audit activities.Become a trainer for the eQMS.Work with Research and Development to efficiently qualify new components; assist suppliers in creating of statistical sampling plans, inspection methodology and quality procedures for new components.Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities.Other requirements as identified during the execution of this role.REQUIRED KNOWLEDGE, SKILLS AND ABILITIES In depth familiarity with the ISO, MDD/MDR, FDA and the medical device industry quality requirements associated with product development, design controls, and product risk management.Detailed understanding and working knowledge of Medical Device Directive/ Medical Device Regulation, EN ISO 13485, EN ISO 14971, IEC 60601US is required, as well as US regulations 21CFR820.Strong communication and presentation skills.Competent with use of Microsoft Office Suite and Minitab Statistical Analysis software (or equivalent).MINIMUM REQUIRED EDUCATION AND EXPERIENCE 3-5+ years of medical device or pharmaceutical engineering experience preferred.BS in Mechanical, Electrical, Biomedical Engineering or Pharmaceutical Chemistry.MS strongly preferred.Company BVI is refocusing the future of vision.
As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver (Knives and Blades), Visitec (Cannulas), Malosa (Single-Use Instruments), Vitreq (Vitreoretinal Surgical Products) and PhysIOL (Premium IOLs), and spans more than 90 countries.
We've set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept – taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus.
Learn more at www.bvimedical.com
#J-18808-Ljbffr
