Quality Assurance & Configuration Engineer

Quality Assurance & Configuration Engineer

We are seeking a skilled and experienced Quality assurance & Document/Configuration Control engineer to join our medical team, The Quality assurance is responsible for driving product quality, providing manufacturing and/or engineering process support through documented procedures and practices. This position is a key technical role responsible for developing, implementing, improving, and continuously reinforcing established QA fundamental practices utilized at the company business. The role involves hands-on work in the areas of design controls, design transfer, manufacturing, and distribution.

Quality Assurance (50%)

Position Description:

• Lead Design & Development Quality activities for new products. Participate in all aspects of the creation and execution of functional/design requirements for new products (NPI team member);

• Taking an active role in supporting and approving design verification/validation activities;

• Enhance the design control and risk management processes to better reflect state-of-the-art practices and drive continuous improvement;

• Provide leadership in all areas of the Quality System, including, but not limited to CAPA, product complaints, nonconforming materials (MRB), risk management, QMRs, etc.’;

• Support external and internal audit activities in the company, and drive company readiness activities;

• Participate and support company defect management life cycle process (DRB, SDLC);

• Work closely with suppliers on the qualification of new parts and processes supporting product development; Conduct assessments of new suppliers as part of the project teams;

• Responsible for overall company training plans and objectives.

Document & Configuration control (50%)

Position Description:

• Manage CCB meeting – CCB Charman (ECO)

• Responsibility for the establishment and maintenance of items, BOMs, and changes in the PLM system

• Responsibility for managing the configuration and information of all products in the company

• Responsibility for implementation, approval of documentation, and release of production files

• Responsibility for the engineering information (product files and drawings) at subcontractors

• Responsibility for writing and maintaining work instructions for the company's various departments

• Management of DMR and DHF

• Update the Subcontractors about any change in the production files

• Synchronization of the engineering system and ERP

Requirements & Qualifications

• Industrial Engineer or other relevant experience

• Minimum 3 years of experience as QA Engineer in a Medical Device company;

• Experience in ALM (Orcanos) - a significant advantage

• Experience in working and interfacing with ERP systems (Priority) - a significant advantage

• Knowledge of Engineering Change (ECR/ECO) processes and implementation

• Experience in writing working documentation and work instructions.

• Highly proficient in spoken and written English

• Certified auditor – an advantage;

• Ability to read and update blueprints, policies, and procedures to inspect products;

• Basic computer skills, including basic use of Microsoft Office suite software and SAP, or equivalent software;

• Prior work experience in a regulated manufacturing environment (ISO 13485, 21 CFR Part 820, 821);

• Experienced in Identification, Handling, Documenting, and Controlling of Nonconforming products;

• Investigation and Audit experience e.g., root cause analysis preferred

Company Description

Enertec Medical is a strategic partner to the world's leading medical companies, specializing in developing electronic systems for advanced applications. With extensive experience in the military market, Enertec has expanded its expertise to serve the medical and civilian markets, delivering high-quality and complementary systems. The Enertec team consists of highly experienced engineers with expertise in various areas of design, project management, system engineering, manufacturing, and integration.