Essential Functions (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.):
- Develop and maintain quality system related procedures.
- Develop and execute training, including competence assessment, for quality-related processes and procedures
- Create, review and approve Engineering and Manufacturing Change Orders
- Work cross-functionally to conduct root cause investigation, action planning and verification of effectiveness for CAPA
- Work with manufacturing, supply chain, engineering, and others to solve internal and external supplier quality issues; investigate non-conforming product and recommend disposition
- Design, supervise, and perform quality methods such as failure mode effects analysis and statistical process control
- Establish and maintain systems/methods to monitor incoming, in-process and shipped product quality to ensure safety and performance, identify trends and drive improvements
- Communicate with local, global and corporate functions and customers, as needed, to resolve system and product quality issues, including customer complaints
- Drive Quality Planning Process including FMEA (Risk Management), Control Plan and Process Audit, etc.
- Establish and maintain inspection procedures based on the material/product specifications and customer requirements
Competencies (Knowledge and Skills needed for this position.):
- Strong verbal and written communication skills
- Problem solving skills
- Detail oriented
- Root cause analysis
- Risk assessments
- Excellent organizations skills to manage multiple priorities
- Self-directed
- Drive continuous improvement throughout the organization
Desired Qualifications:Required Education: Bachelor's Degree in Engineering or equivalent experience.
Experience:- 2+ years related work experience: (Quality Engineering, Quality Control, Quality Improvement Projects, Root Cause Analysis, CAPA) preferred.
- Experience in Medical Device Manufacturing, ISO 13485, highly preferred.
Other Information:Direct reports: N/A
Indirect reports: N/A
Working Environment: Manufacturing facility and office environment.
Physical Demands: Sitting, standing, lifting, bending, reaching, no more than 20 lbs.
Position Type and Expected Hours of Work: Full-time position (Monday-Friday).
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
