Senior Quality Engineer

BD Medical
Employment Type
Not disclosed
BD Medical logo

Job Description Summary
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.

Job Description

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

Position Requirements:

Education: BS degree in Engineering, or other scientific discipline.

Experience: Minimum of 5 years of relevant experience (Medical Device/ Pharmaceutical)

Special Skills:

  • Thorough understanding of industry regulations/standards: ISO 13485, QSR, GMP
  • Knowledge of design control principles.
  • Good understanding of statistical methods for Quality Assurance
  • General working knowledge of the six-sigma process methodology
  • Experience in Quality System, Six Sigma Methodology, Validation, FMEA/Risk Management.
  • Knowledge and experience in manufacturing
  • 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

Primary Work Location
IRL Dun Laoghaire – Pottery Road

Additional Locations

Work Shift