Job Summary
Provides technical support to the maintenance and improvement of the quality systems. Develops quality standards and controls. Develops, process and systems qualification protocols for new systems and existing manufacturing production lines. Advises company management on quality assurance requirements. Review non-conformance reports along with product risk assessment and performs root cause investigations.
Job Details/Responsibilities
Quality engineering, system and process validation, project team leadership and participation, document generation and control, data analysis, corrective and preventive action.
- Prepares and implements quality standards, operating procedures and reporting systems.
- Conducts training to end-users of Quality Management Systems, specifically the CAPA process.
- Supports CAPA and auditing programs and performs assigned actions to address quality issues.
- Interacts with cross-functional teams to obtain system requirements and feedback to implement preventive and/or corrective actions.
- Manages and provides status of assigned projects to the management team. Identifies areas of risk and recommends mitigation actions.
- Prepares and implements proposals of improvement to the quality management system. Provides follow-up actions as necessary.
- Develops quality plans, validation plans, risk assessments and other validation related deliverables for the implementation of the CAPA Process.
- Ensures quality system compliance for areas of responsibility.
- Reviews, approves changes under the change management system, as required.
- Initiate investigations and product performance risk analysis for issues related to the quality management system.
- Leads CAPA Review Board meetings
Working Conditions/Physical Requirements
QUALITY REQUIREMENTS
- Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives
- Work within the QMS at all times, ensure accurate completion of records and highlight issues to immediate supervisor any issues affecting quality
- Responsible to ensure facility, processes and documentation remain in a state of audit readiness at all times
EH&S REQUIREMENTS
- Take care of your own health and safety and that of others who maybe affected by your actions
- Work co-operatively to highlight issues affecting Environmental Health and Safety
Knowledge, Skills and Abilities (KSA)
- Excellent Written and Verbal Communication
- Understanding of quality system regulations (ISO13485, 21CFR820)
- Working knowledge of Computerized System Validation requirements for Medical Devices (21CFR Part 11).
- Ability to interact with all levels within organization
- Analytical skills for compiling and analyzing data
- Systems and customer service oriented.
- Knowledge of DOE, SPC, Gage R&R, and sampling plans
- Computer and software skills
- Ability to motivate others and work independently
Qualifications/ Background Experiences
- Bachelor’s degree in a technical discipline, or equivalent, with a minimum of five years of experience in medical device quality assurance.
- Experience with class III cardiovascular medical devices
- Thorough understanding of quality system regulations (e.g. 21CFR820, ISO 13485)
