Design Quality Engineer

Job Description

Who we are
TCS medical devices division is a thought leader in providing complete solutions to the medical device industry. Large pool of medical device engineers and consultants provide services in engineering, which span the product life cycle, that is from ideation to product commercialization and supply chain management. TCS has been working in this industry for over 20 years supporting 22+ customers across geographies and 9 of the Top 10 Medical Device companies. TCS brings in deep domain knowledge, extensive experience in R&D, Manufacturing and Quality & Regulatory compliance along with Partner Eco-system comprising of TCS Co-innovation network, TRDDC, TCS Innovation Labs, Clinical eco-system & TATA Group companies.

TCS enables MedTech customers introduce differentiated products faster, product line rationalization, and digitization of products and processes with reduced Total Cost of Ownership. TCS solutions span through prevention, diagnosis, treatment, and care across the healthcare cycle. Our key offerings include New Product/ Technology Development, Front-end Innovation, Digital Product Engineering, Emerging Market Product Development, Software-as-a-Medical Device, Design to Value & Product Sustenance. We have 5,000+ person years of experience in product design & development across multiple therapeutic areas.

 
What we need 
We are looking for Design Quality Engineer in Galway, Ireland

Job Purpose and Primary Objectives:

• To provide Design Quality Support and lead relevant activities

Key responsibilities:

• Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and corporate procedures and guidelines, the duties and responsibilities for this position are:
• Collaborate with other functional groups in support of new product development projects
• Develop and establish effective quality control and associated risk management plans
• Write, review and/or approve process and product validation protocols and reports, equipment qualifications, engineering change orders.
• Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE)
• Direct Failure Mode and Effects Analysis activities for both Design and Process FMEA's
• Determine sterility, biological and packaging test requirements utilizing appropriate industry or agency standards for new products
• Ensure that development activities follow design control requirements, product is tested per applicable standards, European Essential Requirements are met per the MDD, and product is properly transferred to manufacturing
• Provide all planning necessary to ensure effective product acceptance. This includes, but is not limited to, inspection instructions, equipment and gage requirements, and sampling plans.
• Support closure of Corrective and Preventative Actions (CAPA) and Non-Conformances (NC)
• Support production floor activities (IQ/OQ/PQ) and product quality investigations
• Assist in complaint analysis as appropriate
• Assist Regulatory Affairs in developing submissions for new devices as necessary.
• Participate in design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes
• Recommend issue resolution to senior management for significant capability and compliance issues
• Plans, develops, coordinates, and directs one or more large important engineering project or a number of small projects with many complex features.
• Carries out complex or novel assignments requiring the development of new or improved techniques or procedures
• Develop and evaluate plans and criteria for a variety of projects and activities to be carried out by others
• Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment when necessary data are insufficient or confirmation by testing is advisable
• Performs other duties assigned as needed.
• Responsible for communicating business related issues or opportunities to next management level
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

Key Skills/Knowledge:

• Experience in QA activities associated with a manufacturing environment
• American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable
• Knowledge of FDA’s 21 CFR Part 820 (Quality System Regulation), ISO 13485:2016, the European Medical Device Directive, and the Canadian Medical Device Regulations.
• Knowledge of Quality and operations systems and processes, including GMP and QSR requirements for medical devices
• Knowledge of leading-edge Quality Engineering, design control, and verification and validation (V&V) tools and methodologies
• Results and deadline driven with an ability to handle multiple tasks and operate in a fast-paced environment.
• Excellent interpersonal skills and ability to work with people to achieve results.
• Excellent written and communication skills, fluency in English.
• Good judgment/decision making and problem-solving ability, capable of understanding the impact of decision making on both client and their customers.
• Highly motivated and an enthusiastic self-starter with the ability to work under own initiative and as a team player.
• Proficiency in MS office products.
• Good business acumen.
• Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience

Experience required:

• Bachelor's Degree in Engineering, Science, or related technical field
• Proven experience as QA, in Quality Systems or regulatory experience in the medical industry is a prerequisite
• Auditor certification from an industry recognized organization is preferable.
• Experience in preparation for notified body and FDA inspections

Person Specification:

• Client facing, Strong Communication

What you get

TCS is one of the fastest growing companies in the UK & Ireland. Joining TCS at this pivotal time will expose you to numerous domains and projects. We are consistently voted number one in customer satisfaction and Top Employer in the UK and globally.

We provide competitive salaries which include pension, health care, life insurance, laptop, phone, access to extensive training resources, and discounts within the larger Tata network.