Senior Quality Engineer

HERO

Job Detail

Location Dublin
Salary Negotiable
Posted
Role Type Permanent
Contact Mark Wilson
email talent@hero.ie

Senior Quality Engineer

Apply Now

Job ID: JOB-13102
Senior Quality Engineer



Location: Blackrock

Reporting to the Senior Manager, Quality Engineering for the Franklin Lakes design center, the Senior Quality Engineer for the Wearable Injector platform is responsible for supporting design control activities; responsible for problem-solving approaches and analytical skills to support new product development and product maintenance using quality engineering skills including but not limited to process validation, measurement system analysis, root cause analysis.

The position ensures all design control and production/ process control projects meet applicable regulatory (local and international), corporate and unit requirements.

Requires the ability to handle multiple projects, from product inception through product launch and maintenance. In addition, this position will play an active role in the processes to ensure products meet quality standards consistent with both corporate and unit policies, while meeting all design control and other regulatory requirements.

Main Responsibilities:

  • Assist/conduct Failure Investigations and problem-solving sessions for non-conforming products
  • Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods process validation, etc.
  • Contributes to the completion of specific programs and projects
  • Independently determines and develops approach to solution
  • May provide guidance and work direction to other team members
  • Liaise with Manufacturing Plants
  • Provide functional support to cross-functional teams
  • Define product control strategy
  • Lead risk management activities
  • Ensure design control elements are satisfied
  • Ensure/ perform process validation activities
  • Support supplier qualification activities – risk classification assessment and product quality assessments
  • Evaluate test methods used in project activities
  • Evaluation of customer requirements to identify applicable quality standards
  • Release product (customer samples) during development activities
  • Realization of quality functional reviews
  • Ensure implementation of Pharmaceutical Systems global procedures and standards for QE engineering activities
  • Provide support to internal, regulatory body and customer audits and associated corrective actions.
  • Supports continuous improvement of current products and practices to improve quality, customer experience, and worldwide market share
  • Support new customer onboarding activities – pre-feasibility and feasibility work

Education and Experience:

  • Minimum of 5 years of relevant experience (Medical Device/ Pharmaceutical) BS degree in Engineering, or other scientific discipline.
  • Good understanding of Statistical Methods for Quality Assurance General working knowledge of the six-sigma process methodology
  • Thorough understanding of industry regulations: QSR/cGMP, ISO QM standards
  • Good written and oral communication skills
  • Excellent problem solving and analytical skills
  • Ability to handle multiple projects simultaneously in an unsupervised environment
  • Ability to thoroughly evaluate, clearly understand and communicate all aspects of assigned project.

For further information on this role in please contact Mark Wilson on 0860449473 or email talent@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given.  You have supplied us with your personal data in the process of applying for a position.  Our client company may have personnel outside of the EEA who will review you data.  We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Mark Wilson

JOB-13102

Apply Now

Senior Quality Engineer

Mark Wilson

Role Type Permanent
Contact Mark Wilson
email talent@hero.ie
mobile +353 86 044 94 73
linkedIn profile click here

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