Quality Engineer
Job ID
129140
Job Type
Contract
Industry
Manufacturing
Location
Madison, Wisconsin, United States
Talascend is seeking qualified candidates to apply for a Quality Engineer position located in Madison, WI.
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.
RESPONSIBILITIES:
* Perform trending and analysis of customer complaint data
* Drive investigations and manage deviations and NCMRs from initiation to disposition
* Perform and lead RCAs 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
QUALIFICATIONS:
* Bachelors, 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
* Proficient with Microsoft Office tools, especially Excel
* Technical writing
* Statistical analysis - Minitab or other software equivalent, preferred.
* 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
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.
RESPONSIBILITIES:
* Perform trending and analysis of customer complaint data
* Drive investigations and manage deviations and NCMRs from initiation to disposition
* Perform and lead RCAs 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
QUALIFICATIONS:
* Bachelors, 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
* Proficient with Microsoft Office tools, especially Excel
* Technical writing
* Statistical analysis - Minitab or other software equivalent, preferred.
* 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
We thank all applicants for their interest. However, only those qualified individuals who closely meet the qualifications of the position will be contacted. The details of the position are only a summary, other duties may be assigned as necessary.
Background Check and Drug Screen may be required.
Talascend is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.