Immediate start

County Donegal

Careers at TCS: It means more

TCS is a purpose-led transformation company, built on belief. We don’t just help businesses to transform through technology. We support them in making a meaningful difference to the people and communities they serve - our clients include some of the biggest brands in Ireland and worldwide. For you, it means more opportunity to make an impact that matters, through challenging projects which demand ambitious innovation.

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 Graduate Design Quality Engineer for our medical devices division.

Key Responsibilities:

  • 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
  • Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment when data are insufficient or confirmation by testing is advisable
  • Collaborate with other functional groups in support of new product development projects

Rewards & Benefits

TCS is consistently voted a Top Employer in the UK&I and globally. Our competitive salary packages feature pension, health care, life assurance, laptop, phone, access to extensive training resources and discounts within the larger Tata network.

Diversity, Inclusion & Wellbeing

At TCS, we believe in building and sustaining a culture of equity and belonging where everyone can thrive. Our diversity motto is ‘Inclusion without Exception’.

We encourage applications from all sections of society. As an equal opportunity employer, we do not discriminate on grounds of race, religion or belief, ethnic or national origin, disability, age, sex, pregnancy and maternity, citizenship, marital, domestic or civil partnership status, sexual orientation, gender reassignment, gender identity, or any other basis as protected by applicable law.

TCS is committed to working with and providing reasonable accommodations to its employees and applicants for employment to ensure that individuals with disabilities enjoy equal access to all employment opportunities. If you are an applicant who needs an accommodation due to a disability to complete an employment application or during any phase of the hiring process, please contact us at jennifer.long@tcs.com with the subject line: "Disability Accommodation Request".

Due to a high volume of applications, we will be unable to contact each applicant individually regarding the status of their application. If you have not received a direct response within 30 days, then the application should be deemed unsuccessful.

More Details

Apply by

10.02.2022

Start date

Locations

Letterkenny

Regions

County Donegal

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