Elixir Medical Corporation

Principal Quality Engineer

Elixir Medical Corporation, Milpitas, CA, United States

MAJOR DUTIES AND RESPONSIBILITIES

Responsibilities include:

Support new product development projects to include the following: (1) Design control, risk management, biocompatibility, verification/validation testing, sterilization, packaging, and change control.
Provide Quality Engineering leadership and support for commercial medical device production: (1) Test method assessment and improvement (Test Method Validation, GR&R). Perform data analysis, trending, change control, and deviation support activities. (2) NCR, Complaints and CAPA investigation and review, including: risk analysis, impact assessment, root cause analysis tools, and material dispositions.
Receiving and Incoming Inspection Process Management: (1) Materials handling and transfer management and improvements. This will include development, clinical, and commercial phase-appropriate controls. (2) Component specification implementation, revision, and management. (3) Provide technical support for routine incoming inspection
Equipment management and validation activities. Establish IQ/OQ, preventive maintenance and calibration requirements.Review software risk assessments, validation protocols and reports.
Clean room and CDA (re-)qualification and periodic monitoring processes (particulate, airflow, and viables). Environmental monitoring system management (Rees), updates and validation.
Support activities related to sterilization management (ETO and E-beam).
Support other quality system processes as needed, and audits by regulatory agencies and third parties.

QUALIFICATIONS

Experience

Minimum 10 years medical device (Class III preferred) 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.
Computer skills: Microsoft Office (Word, Excel, PowerPoint), and statistical software such as Minitab or JMP.
Must be familiar with sampling plans such as ANSI Z1.4, Z1.9, and zero acceptance number sampling.
Must be familiar with root cause analysis tools (6Ms, 5 whys, fishbone/Ishikawa diagrams, etc.)

EDUCATION REQUIREMENTS