Senior Quality Engineer

Location: Bedford, MA

Summary of Primary Responsibilities:

This position is responsible for providing support for new product development and manufacturing support for commercial products. This key technical role will support the development and manufacture of medical device and drug/device combination products by providing expertise on regulated standards processes such as design control, human factors/usability engineering, and risk management.. Working closely with Operations, Manufacturing Engineering and Research and Development Engineering, the Senior Quality Engineer ensures a high level of product quality and effective and efficient corrective and preventive action plans.

Specific Responsibilities:

  • Designs, evaluates and implements quality assurance programs and systems for manufacturing and product development to ensure compliance with regulatory requirements
  • Lead investigations, performs root cause analysis, prepares detailed investigation reports and implements corrective actions
  • Develops, reviews protocols and reports to ensure quality attributes and analysis are being conducted
  • Participates in the development of customer requirements and design inputs; works with team to ensure that customer requirements (user needs) can be validated and design requirements can be verified
  • Facilitates the Risk Management Process in accordance with the latest version of ISO 14971; ensures integration of risk management outputs with design, process and regulatory requirements
  • Designs and maintains procedures and systems for process and quality data collection
  • Conducts and/or supports process capability evaluations and determines critical process control points and appropriate control limits.
  • Oversees equipment and process validation methods to ensure they are properly validated prior to implementation and critical equipment is periodically re-validated
  • Conducts gap analyses of in-house practices versus relevant regulations, standards and industry practices; develops plans and implements corrective actions to ensure continued compliance
  • Performs other related duties as assigned

Job Complexity:

Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.  Exercises judgment within generally defined practices and policies in selecting method and techniques for obtaining solutions.  Requires thorough knowledge of FDA, ISO, and other regulatory guidelines related to the manufacturing of medical devices.

Supervisor Responsibilities:

No direct reports.  Has responsibility to oversee diverse teams in the implementation of projects.

Experience, Knowledge and Skills Required:

  • Requires a Bachelor’s Degree in engineering or related discipline with a minimum of 5 years related experience and demonstrated working knowledge of scientific principles; Master’s Degree preferred
  • Strong knowledge of statistical process control methods and techniques
  • Working knowledge and demonstrated application of ISO 14971 Risk Management for Medical Devices
  • Working knowledge of cGMPs, QSRs, MDDs
  • Familiarity with the principles of Design Control
  • Working knowledge of Six Sigma a plus
  • Strong writing and presentation skills

We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.