Quality Engineer

Job Title

Quality Engineer

Requisition

JR000015762 Quality Engineer (Open)

Location

Madison, WI

Additional Locations

Job Description Summary

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.

Job Description

Essential Functions

• 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 of 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

Education / Experience / Skills:

• Bachelor’s, or higher, degree in engineering or applicable science/technology program and 3+ years of experience in a cGMP Quality Assurance/Compliant environment (medical devices preferred) OR

• Associate’s degree with 10+ years of experience in cGMP Quality Assurance (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

• Ability to travel (5-10%)

Competencies:

• Proficient with Microsoft Office tools, especially Excel, Word and PowerPoint

• Technical writing

• Statistical analysis – Minitab or other software equivalent, preferred.

• ASQ Certification (preferred)

Organizational Relationship/Scope:

The Quality Engineer collaborates closely with Manufacturing, Engineering, Quality Control, Facilities, Materials Management, Regulatory Affairs, Maintenance/Metrology, and site external entities (Distribution Operations, Customer Care, Quality Compliance, etc.). The individual must be able to perform in a fast-paced environment with strict adherence to timelines. This position reports directly to the Quality Assurance Manager. It is the expectation this position works during normal business hours M-F, but work may be performed outside normal business hours when required to support business needs.

Working Conditions:

The Quality Engineer will mainly work in an office environment but may also be required to work in manufacturing, warehousing, and laboratory areas.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support—showing up in big moments and small to help patients find comfort and confidence.

We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men’s health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.

We are Keenova—keen to solve, keen to serve. Learn more at www.keenova.com.

At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support—showing up in big moments and small to help patients find comfort and confidence.

 

We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men’s health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.

 

We are Keenova—keen to solve, keen to serve. Learn more at www.keenova.com.