Major Duties and Responsibilities
Provide Quality Engineering leadership and support for commercial medical device production:
- Test method assessment and improvement (Test Method Validation, GR&R). Perform data analysis, trending, change control, and deviation support activities.
- NCR, Complaints and CAPA investigation and review, including: risk analysis, impact assessment, root cause analysis tools, and material dispositions.
- General quality support for manufacturing operations
Receiving and Incoming Inspection Process Management:
- Materials handling and transfer management and improvements. This will include development, clinical, and commercial phase-appropriate controls
- Component specification implementation, revision, and management
- 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
Other responsibilities:
- Clean room and CDA (re-)qualification and periodic monitoring processes (particulate, airflow, 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
- Support audits by regulatory agencies and third parties
Qualifications and Skills
- Minimum 8 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 conclusionsComputer
- 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