Join us today and make a difference in people's lives! We are looking for a Design Quality Engineer for our plant in Mirandola (MO).
The Design Quality Engineer will contribute to ensure that product development, production, and process control activities are conducted in compliance with the company quality system and the international regulations governing medical device manufacturing and distribution.
You will be part of LivaNova, a global medical technology company, worldwide leader in cardiovascular and neuromodulation solutions. With almost 3,000 colleagues in more than 100 countries, we are facing steady commercial growth to help create products and therapies that transform people's lives.
JOB FUNCTIONS: With respect to the Design Control & Production and Process control, He/She:
Actively works with R&D and process to define product and process requirements.Establishes product quality control plans.Reviews design product validation planning, protocols, and reports.Reviews process validation planning, protocols, and reports.Performs preliminary review of the change impact assessment to confirm that quality requirements are met.Coordinates investigations of the cause of V&V failures.Identifies opportunities for quality improvements in the production area and leads improvement plans.With respect to Nonconforming product handling, He/She:
Collects and critically analyzes data and takes disposition decisions on nonconforming products identified in production.Leads proper investigation to identify the causes of components/product failures (nonconforming products from production and complaints).Generates the evaluation of the risk posed by the observed NC on products already distributed (HHA) to determine if Stop Shipment and/or FSCA are indicated.Owns CAPA process and trends data to identify opportunities for CAPA.Whenever applicable, supports external manufacturers of semi-finished and finished products in the management of any detected non-conformities.Notifies suppliers of any non-conformance related to purchased material and evaluates corrective actions consistency versus the internal production process.Provides support to the batch record review for subassemblies/semi-finished products when needed.He/She respects the Health and Safety Regulations in his/her field of competence.
REQUIREMENTS: Degree in Technical and Scientific disciplines (Physics, Chemistry, Engineering, and Biology).Good knowledge of English (written and spoken).1-3 years of experience in medical device or pharmaceutical companies in QA departments.Must have: Experience on design and development product process.Depth knowledge of Microsoft Office suite.Deep knowledge of ISO13485.Good knowledge of Good Manufacturing Practices.Our commitment to Diversity & Inclusion: LivaNova values equality and celebrates diversity. We are committed to ensuring that our recruitment process is fair, transparent, and free from unlawful discrimination.
Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate's sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.
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