Top 5 Qa Analyst Jobs in Madison, WI

Senior Quality Analyst/Engineer
Stellar IT Solutions LLC —Madison, WI
- $45 - $50 an hour
- Weekends as needed
- Microsoft Excel
- 5 years
- Office
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Senior Quality Analyst/Engineer
Robotics Technologies —Madison, WI
- Team management
- US work authorization
- Senior level

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Senior Quality Analyst/Engineer

Stellar IT Solutions LLC -
Madison, WI

Quick Apply

Job Details

Contract
$45 - $50 an hour

Qualifications

Statistics
Microsoft Excel
Team leadership
Coaching
Technical writing experience within manufacturing
GMP
Project management experience in manufacturing
Change management
Mentoring

Full Job Description

Job Title: Senior Quality Analyst/Engineer

Job Type: Contract

Job Location: Madison, WI

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

Minimum Requirements

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

Competencies:

Proficient with Microsoft Office tools, especially Excel, Word and Powerpoint

Technical writing

Statistical analysis - Minitab or other software equivalent, preferred.

Organizational Relationship/Scope:

The Senior Quality Analyst collaborates closely with Manufacturing, Quality Control, Engineering, 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 onsite during normal working hours M-F, but may be required to work extra hours or on weekends or holidays in order to support business needs.

Working Conditions:

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

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Senior Quality Analyst/Engineer

Senior Quality Analyst/Engineer

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