Quality Engineer II
1 month ago
Primary Function:
This position brings value to the organization by providing thorough technical review of all documents generated for inclusion in the Design History Files and process validation files, as well as for investigating customer complaints. The person(s) in this position will play a critical role in evaluating risks impacting the CBI quality system. Additionally, this position will perform related duties as determined by the department manager.
Essential Job Functions/Duties:
Responsibility:
- Supports design control by:
- Participation in design reviews and design input discussions
- Participation in protocol development
- Review and approval of all documents generated in the development of the Design History File for protocol fulfillment, statistical validity, regulatory compliance and auditability
- Participation in risk management activities
- Review and approval of all process validation protocols and reports
- Review and close customer complaints, assist in investigation of non-clinical complaints
- Conduct risk assessment pertaining to CAPA’s, complaints, NCMR’s, deviations, etc.
- Active participation in CAPA resolution and determining effectiveness
- Collaborate with Clinical, Engineering, Regulatory and Operations personnel to perform complaint investigations
- Evaluate / audit new production processes for critical control points and recommend solutions
- Sponsor / coordinate CAPA activities
- Participate in internal audits
Knowledge:
- Understand and apply the understanding of FDA QSR, MDSAP, Canadian and ISO 13485 Quality System
- Requirements in carrying out duties
- Understands and deploys best practices associated Quality engineering processes
- Collaboration
- Collaborate with Clinical, Engineering, Regulatory and Operations personnel to perform complaint investigations
- Collaborates within the QA team and others not part of the QA team
- Change / Innovation
- Proposes ideas and implements incremental improvements
Decision Making
- Moderately independent, consults supervisor
- Minimum Work Experience/Educational Requirements:
- Collaborate with Clinical, Engineering, Regulatory and
- Operations personnel to perform complaint investigations
- Evaluate / audit new production processes for critical control points and recommend solutions
- Sponsor / coordinate CAPA activities
- Participate in internal audits
Physical Requirements/Work Environment:
- Must be able to perform the essential functions of the job, with or without reasonable accommodations
- Limited exposure to hazardous chemicals used in the manufacture of the product
- Physical demands are typical of an office and classroom environment
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