Quality Engineer

Pay rate: $45.00- $48.50/hr
Hours: Hours M-Th 9 hours, F 4 hours. Optional overtime can be requested.
Location: Madison, WI
Duration: 6 months


Summary:
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 the Regulatory Affairs, Operations, Technical Operations, Engineering, and Materials Management groups to drive quality culture.


Principal Responsibilities
• 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
• Leading 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.


Department specific/Non-essential responsibilities:
• 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


Competencies:
• Proficient with Microsoft Office tools, especially Excel, Word and Powerpoint
• Technical writing
• Statistical analysis - Minitab or other software equivalent, preferred.


Experience / Skills:
• 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
• Leadership skills / Emotional Intelligence
• Ability to utilize statistics at a moderate level for trending and interpretation of statistical data


Working Conditions:
The Senior Quality Analyst will mainly work in an office environment. Domestic and international travel will be required on a limited basis.


Benefits (employee contribution):

• Health insurance
• Health savings account
• Dental insurance
• Vision insurance
• Flexible spending accounts
• Life insurance
• Retirement plan

ll qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Rate of pay within the stated range will depend on the qualification of the applicant.