Quality Assurance Manager/ Engineer Medtech

For our medical device clients in Switzerland we are constantly looking to connect with experienced professionals in several areas, including pre-clinical development, clinical research, medical affairs, regulatory affairs, quality assurance etc.

One of the roles we often recruit for is aQuality Assurance Manager/ Engineer Medtech. The major goal is to keep track of complaint activity and provides input to modify existing manufacturing processes .Supports of the Quality Management System (Operation & Maintenance) as it relates to service and distribution activities (post manufacturing) to meet compliance programs in accordance with MDD/MDR, IVD/IVDR, ISO 13485

Main Responsibilities

• Successfully address quality issues of finished goods and related processes to assure that products meet intended use and customer acceptance levels per company SOPs and regulatory standards.
• Reports events that meet defined reporting criteria to regulatory agencies in accordance with laws and regulations.
• Collaborate with relevant departments and stakeholders to investigate non-conformances, defects and product failures in general in order to identify areas in need of product improvement, to determine the cost of quality and to lead or participate in resolution.
• Ensures that all complaints are reported accurately, screened for potential safety issues, and closed out in a timely manner as per the corporate procedures.
• Reports customer product defect complaints.
• Assesses potential safety issues and determines all the incidents deemed reportable as per the vigilance system (MEDDEV 2.12-1 and corporate SOP).
• Completes and files incident reports and reports to competent authorities within the timeframes. Prepares the customer responses.
• Generates, maintains and completes the complaint files subject to review by regulatory agencies.
• Manage quality activities pertaining to the Non-Conforming Events and Corrective/Preventive Actions for non-manufacturing locations, which includes the control, segregation, labelling and disposition of non-conforming or suspected non-conforming materials at European Technical Centre.
• Performing regular inspections and assessments of sub-contracted activities, including EU Centre.
• Coordinates and partners with different departments (Field Service, Sales, Marketing, Quality, Customer Support, Production) to help appropriately resolve customer issues and product defects at Service Centre
• Reviews and analyses trends from data and summarizes appropriately. Provides reports for applicable quality meetings.

Qualification, Experience and Key Competencies

• RelevantSwissworking/residencypermitorSwiss/EU-Citizenship required;
• Bachelor’s degree in scientific / healthcare / engineering
• Minimum of 5 years of experience in the quality in the medical device industry
• Proficient in English written and verbal communication skills, additional EU language is a plus
• Ability to understand technical specifications
• Experience in quality auditing would a plus
• Experience in quality management or regulatory affairs (ISO 13485, 21 CFR 820, EU 2017/745