Share this Job Senior Quality Engineer - Design Assurance

MERCK
Posted on

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Executive / senior industry position

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Your role: As a Senior Design Assurance Quality Engineer in the Biotools area you are responsible for maintaining the design control activities associated with the Medical Device portfolio. Working closely with the Operations & Sustaining Engineering teams you ensure Design History Files are in compliance with the latest Quality and Regulatory requirements.  You assess change controls for impact on Product Design History Files & Design Verification.  Support sustaining commercial projects from a Design Assurance perspective. You will be directly involved in making sure products are maintained through the full product lifecycle and that these products comply with global standards.  Support the introduction/implementation of product/process/materials changes to the manufacturing operation. You will assess the risk appropriately for these design changes. You will provide QA technical direction/input to qualification and validation activities in conjunction with Mfg. Engineering.  Responsible for generation and completion of Design Verification protocols & design verification reports.

The position is located in Carrigtwohill Co Cork, Ireland

 

  • 3-5+ years of experience in design assurance, new product development or related medical device experience
  • Self-starter and independent critical thinker, with the aptitude to work autonomously and within a team 
  • Strong interpersonal, organizational, and project management skills
  • Demonstrated use of Quality tools/methodologies.
  • ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis

 

 

Our portfolio extends from liquid crystals for displays and pigments for automotive coatings to cancer treatments, and your possibilities to develop in our growing company are just as manifold. As a stock-listed company we still make history – not least because we take responsibility for our employees, products, the environment and society. We offer a modern and international working environment to unleash your innovative potential in diverse teams

 

Working time model:  full-time

US Disclosure The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.North America Disclosure The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

Job Segment: Medical, Product Development, QA, Quality Assurance, Quality, Healthcare, Research, Technology

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Posted on

Type

Executive / senior industry position

Carrigtwohill%2C%20Ireland

Carrigtwohill , Ireland