Senior Quality Engineer – Medical Devices

Job Summary

Job Title: Senior Quality Engineer – Medical Devices

Duration: 6 months with possible extension up to 18 months

Location: 6603 Femrite Dr, Madison, WI 53718, USA

Pay Rate: $45-$48/hr. on W2 with Select Source International

• The Senior Quality Analyst/Engineer is responsible for assuring that activities, processes, and product related to managing the processes of CAPA, Change Management, investigations, deviations, Quality Management Review, Audit coordination, and metrics for the Madison facility. This position will have a wide range of tasks which may include Quality System improvement initiatives, data maintenance, trending and reporting, deviation investigation, internal/external auditing, and direct involvement and collaboration with Regulatory Affairs, Operations, Technical Operations, Engineering, and Materials Management groups to drive quality culture.
• Develop and maintain quality system processes, including metrics reporting and tracking
• Manage CAPA initiation, review, surveillance, and reporting
• Facilitate the site Quality Management reviews
• Facilitate and lead the site Change Management process
• Support and lead root cause analyses through cross functional team involvement
• Lead Good Documentation Practice training and Quality on the Floor coordination and performance
• Interpret and properly apply all applicable regulatory requirements
• Coordinate and provide direct support for facility audits by internal and external entities
• Manage data collection and reporting when product recalls are required
• Perform trending of Quality Systems to support FDA and Management reviews
• Improve quality culture through site initiatives and improve existing procedures to better align with regulatory requirements
• Review and approval of procedures, protocols, reports, etc., as required
• Filing and management of documentation when required
• Supporting other Quality System Functions
• This role may be required to lead personnel (inside and outside) the Quality organization in support of the business need

• Bachelor’s, or higher, degree in science/technology program preferred
• 5+ years of Quality Assurance 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
• Ability to utilize statistics at a moderate level for trending and interpretation of statistical data
• Proficient with Microsoft Office tools, especially Excel, Word and Power Point
• Technical writing
• Statistical analysis – Minitab or other software equivalent, preferred