Mallinckrodt Pharmaceuticals Madison , WI 53706
Posted 2 weeks ago
Job Title
Quality Analyst
Requisition
JR000014219 Quality Analyst (Open)
Location
CC-Madison
Additional Locations
Madison, WI
Job Description
The Quality Analyst ensures that all materials, activities, processes, and specified conditions involved in daily device manufacturing, processing, and packaging meet current GMP standards and comply with relevant procedures and standards to maintain product quality integrity. Additionally, the Quality Analyst manages nonconforming material reports, plans material review board meetings, and oversees the status of quarantined and scrapped materials.
Essential Functions
Collaborating regularly with representatives from Quality, Purchasing, Engineering, and Manufacturing to resolve nonconforming material reports.
Tracking and trending nonconforming material reports to ensure quality processes remain controlled.
Analyzing failure modes and performing statistical analysis of nonconforming parts.
Reviewing nonconforming material reports, addressing discrepancies, and escalating issues to management as necessary.
Preparing for material review board meetings and acting as a backup Quality representative during these meetings.
Ensuring all nonconforming parts are properly controlled using the on-site quarantine cage.
Updating the status of all nonconforming parts appropriately within SAP.
Developing, implementing, and maintaining QA procedures, standards, and controls.
Supporting Quality through occasional investigations of nonconformance and assisting with corrective and preventive actions associated with the QA unit.
Performing internal and external audits of systems and suppliers.
Assisting with site audit support.
Managing documentation as required.
Supporting other Quality System functions.
Assisting with the completion of supplier corrective action reports.
Minimum Requirements
Knowledge of FDA CFR 820 and ISO 13485 requirements medical device manufacturing
High level of motivation; ability to work independently.
Ability to communicate well, both verbally and written
Collaborative with strong levels of engagement with individuals and as a team member
Participation experience with internal, external and supplier audits
Preferences:
3+ years working in medical device industry
Strong Statistical background
Auditor Certification (ASQ CQA or CMDA)
Organizational Relationship/Scope:
Reports to the Quality Control Manager. This position is accountable for delivery of the highest quality products according to defined forecast and schedule. Working across multiple functions, this position collaborates primarily with manufacturing and quality to resolve product production related issues.
Working Conditions:
Manufacturing facility of medical devices and accessories. Controlled environmental working conditions. This will be a fully onsite (100%) role.
Mallinckrodt Pharmaceuticals