What are the responsibilities and job description for the Quality Engineer - Medical Devices position at Select Source International?
Description:
The Quality Engineer is responsible for supporting and improving the current Quality Systems within the Madison, WI manufacturing facility. This position will have a wide range of tasks which may include product complaint investigations, root cause analysis (RCA), manufacturing quality process development, maintenance, trending and reporting, deviation investigation, CAPA management, change management, internal/external auditing, supplier quality management, and direct involvement and collaboration with the Operations, Technical Operations, Engineering, and Materials Management groups to drive quality culture.
Principal Responsibilities:
- Perform trending and analysis of customer complaint data
- Drive investigations and manage deviations and NCMRs from initiation to disposition
- Perform and lead RCA’s through cross functional team involvement
- Support the development and maintenance manufacturing quality control processes for new and existing production areas
- Support supplier quality management with respect to desk audit and quality agreement creation, execution and review via direct customer contact
- Maintain process Failure Mode and Effects Analysis for new and existing production areas
- Manage CAPA creation and ensure adequate effectiveness
- Improve existing procedures to align with cGMP and regulatory requirements
- Interpret and properly apply all applicable regulatory requirements
- Improve quality culture through site initiatives
- Review and approval of procedures, protocols, reports, etc… as required.
Department Specific/Non-essential Responsibilities
- Perform internal and external audits of systems and suppliers
- Filing and management of documentation when required
- Supporting other Quality System Functions
Minimum Requirements
Experience / Skills:
- Bachelor’s, or higher, degree in engineering or applicable science/technology program
- 3 years of experience in a cGMP Quality Assurance/Compliant environment (medical devices preferred)
- Effective communication, coaching/mentoring, and presenting skills
- Ability to manage change
- Self-motivated
- Independent and sound decision making capabilities
- Project management to deliver on time results
- Leadership skills / Emotional Intelligence
- Ability to utilize statistics at a moderate level for trending and interpretation of statistical data
Competencies
- Proficient with Microsoft Office tools, especially Excel
- Technical writing
- Statistical analysis – Minitab or other software equivalent, preferred.
Organizational Relationship/Scope
The Quality Engineer collaborates closely with Manufacturing, Quality Control, Facilities, Materials Management, Regulatory Affairs, and Process Development. The individual must be able to perform in a fast-paced environment with strict adherence to timelines. The position is during normal working hours M-F, but may be required to work extra hours or on weekends or holidays in order to support Manufacturing Quality activities.
Working Conditions
The Quality Engineer will mainly work in an office environment but will also be required to work in manufacturing and QC environments when providing QA support to those functional areas.
Is this a Pre-Identified Candidate?
