Principal Quality Engineer

Major Duties and Responsibilities

Responsibilities will include, but not be limited to:

• Provide Quality Engineering support for commercial medical device production:
  • Test method assessment and improvement (Test Method Validation, GR&R). Perform data analysis, trending and change control support activities.
  • NCR investigation and/or review, including: risk analysis, impact assessment, root cause analysis and material dispositions.
  • Deviation and CAPA process support.
• EO and E-beam sterilization process management, sterile load review, validation/re-validation activities, bioburden trending, and quarterly dose audits.
• Complaint investigations, RMA process support, product decontamination, failure mode investigation, root cause analysis, risk assessments, reporting and post-investigation letters.
• Support audits by regulatory agencies and third parties.
• New equipment requisitions, qualification and validation activities. Establish IQ/OQ, preventive maintenance and calibration requirements.
• Clean room and CDA (re-)qualification and periodic monitoring processes (particulate, airflow, and viables).
• New product / R&D:
  • Support new product development projects to include the following:
    
    • Design control, risk management, biocompatibility, verification/validation testing, sterilization, packaging, and change control.

Qualifications

Experience

• Minimum 8 years medical device (Class III) experience with progressive responsibilities.
• Experience in quality systems under applicable cGMP/Quality Systems Regulations (ISO 13485, 21 CFR 820, and MDD/MDR).
• Demonstrated excellent written and oral communication skills with a track record of strong organizational and interpersonal skills. Must be able to define problems, collect data, establish facts, and draw valid conclusions.
• Experience with statistics, sampling plans, Design of Experiments (DOE), and Root Cause Analysis tools (6Ms, 5 whys, fishbone/Ishikawa diagrams, etc.).
• Familiarity with EO and E-beam sterilization desired (ISO 11135 & ISO 11137).
• Experience in both R&D and Manufacturing environments desired.
• Computer skills: Microsoft Office (Word, Excel, PowerPoint), and Statistical Software such as Minitab or JMP.

Education Requirements

• Bachelor’s degree in Engineering or related field

Elixir Medical does not discriminate on the basis of race, sex, color, religion, marital status, national origin, gender, sexual orientation, gender identity, age, military veteran status, disability or any other reason prohibited by law.