Design Assurance Engineer Ne

Design Assurance Engineer
Ne
Liguria, Ne

We are looking for a Design Assurance Engineer, to join our Quality Department , based in Bussolengo (Verona), reporting to the Quality Engineering Manager.

The role is the liaison between Research & Development (R&D), Process Engineering and Quality Operation areas, and Regulatory Affairs area, during the Design & Development of new products and during business as usual with the primary goal to achieve and maintain product specific validations for attributes such as biocompatibility, sterility, reprocessing and packaging.

Additionally the role is expected to : that Design & Development activities are conducted in compliance with internal procedures and in conformity with standards, directives and laws applicable to the Organization; closely with R&D Area promoting specific activities like Risk Management process, design verification, design validation and final release.

Excellent time management and interpersonal relationship skills are necessary in this role.

He/she will interact with Consultants, Subsidiaries, Competent Authorities, Notified Bodies, Distributors, External laboratories and suppliers.

What will your contribution be?

These are related to product aspects such as: sterilization, reprocessing, sterilization and validation; and consist of: of validation test plans, protocols, reports and summaries and coordination of internal and external testing activities of the existing validations according to international/regulatory requirement Additional responsibilities are generic to the Quality Engineering Area: Cooperate with internal departments during the Product Development Process to achieve regulatory release (e. g.

CE marking, FDA approvals) for new products and product modifications.

Manage (i. e.

promote, coordinate and document) the Risk Management activities during the Product Development Process, in relation to product modifications and during post-marketing surveillance.

Manage (promote, coordinate and document), in cooperation with R&D, Marketing, Medical Science and Clinical Affairs, the design validation of new products Prepare and maintain, as required, Technical File documentation for new products or modified products and cooperate with Regulatory Affairs Area to prepare regulatory submissions, and Prepare and maintain Summary Technical Documentation (STED) for regulatory purposes.

Support all the regulatory pre- and post-market activities related to technical aspects.

Support the R&D area to formalize: plan; phase gate documentation; verification documentation; validation.

Implement and update internal procedures relevant to the above mentioned activities Conduct or support internal audits.

Support the preparation and review of relevant product technical & marketing sheets, or ad hoc technical documentation requested to ensure continuity of product supply to the market.

What are we looking for?

Technical degree/ Master's Degree in Engineering with an electronic background 3/5 years in similar position in an implantable medical device company.

Good knowledge of technical standards such as those listed below is a key requirement: 10993 series 11607 series 11137 series F1980 ST79 FDA Guidance 'Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling' Knowledge of relevant regulations and international standards (European MDD, MDR, FDA Guidances, ISO 13485, ISO 14971 etc. ).

Fluent English, both written and oral Very good knowledge and ability to use standard office applications What are you going to improve?

Methodical and critical thinking.

Excellent organizational and project management skills.

Problem solving skills and "can do" attitude Ability to work precisely according to procedures, rules and regulations Adherence to timelines and result oriented attitude Orderliness and attention to detail Analytical approach to resolve complex issues Ability to work in team and autonomously Accountability for the assigned tasks Travel 10-15% What will you find?

Friendly, warm, and innovative atmosphere Healthy, inspiring, and international and inclusive work environment training and development opportunities Smart working model (two days per week) Competitive reward packages Social and company events Wellbeing initiatives (welfare- yoga classes) Canteen Benefits (Pension Fund- Health Insurance) What do we offer?

This is a full-time job The contract is permanent Salary package range: 40. 000/45. 000 euro Do you want to join us?

Are you ready to make the difference?

We look forward to your application.

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