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

• Bachelor’s degree in Engineering or related field