Job Information
Mallinckrodt Pharmaceuticals Quality Engineer in Madison, Wisconsin
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 .
At Keenova, we know that we contribute to something that matters because we make quality products that impact patient lives. Our dynamic work environment provides unique experiences for employees to grow and develop.
Invest in your own career with Keenova and let’s do something dynamic together.
Keenova provides equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religions practices and observances; national origin; pregnancy, childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law.
Additional information on Keenova’s hiring practices may be found by clicking