A bit about us:

We have an outstanding career opportunity for a Quality Engineer with medical device or related manufacturing process analysis experience to join a leading Medical Device Manufacturing Company located in the beautiful St. Louis, MO. area.

The position is responsible supporting lifecycle risk management for medical device products and manufacturing processes.

The position is responsible for periodic review of risk management files to conform with the latest state-of-the-art and assumptions of risk in conformance with ISO 14971.

Why join us?

We offer an exciting and dynamic work environment along with an area competitive compensation plan and an amazingly above average benefits package.

Job Details

Responsibilities:

  • Perform assessment of appropriate risk information to support on-going Post Market Surveillance and Periodic Safety Update Reports in conformance with ISO 14971.
  • Own process risk assessments as needed and performs periodic review to ensure effectiveness of risk mitigation activities.
  • Facilitate risk assessment meetings, documentation of the process and decisions, and follow up of actions.
  • Develop functional area process risk assessments in compliance with MDSAP requirements.
  • Support quality improvement initiatives related to risk management of product and process including but not limited to CAPA investigation and actions, Nonconforming material investigations, input on risk for field actions and customer complaints, maintenance of the risk management file index.
  • Update risk management summary reports as needed.
  • Perform similar device review with the support of subject matter experts in compliance with ISO 14971 and internal procedures.
  • Develop working relationships with key business partners across the firm.

Requirements:

  • 5+ years of experience in medical devices, medical instruments, pharmaceuticals, biotechnology or related industry is required.
  • Direct ISO 14971 Risk Management experience.
  • Requires working knowledge of selection and use of Quality Engineering tools, statistical analysis techniques, data trending or manufacturing process.
  • Experience developing risk assessments (FMEA, FMECA, product safety risk, etc.) to drive improvements and/or maintain processes.
  • Requires knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, IVDR, MDSAP, etc.).

** One of the following certifications is desired for this role: Certified Quality Engineering (CQE), Certified Quality Auditor (CQA), Certified Software Quality Engineer (CSQE), Certified Reliability Engineering (CRE), Certified Biomedical Auditor (BCA), or Six Sigma Black Belt.

  • Requires effective written and oral communication skills to interact across all levels of the organization.
  • Must possess High level of attention to detail, highly motivated and organized.
  • Must have experience in and knowledge of Microsoft Office Package (Word, Excel, etc.)