You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients.

Job Summary

Our client is seeking a Quality Manager who will be responsible for protecting patients and customers post-release. The role involves owning Supplier Quality Management, handling Complaint & Adverse Event (AE) reporting, ensuring readiness for Recall & Traceability execution, and managing Customer Quality/Quality Agreements. The manager will also integrate post-market signals back into the Quality Management System (QMS).

Key Responsibilities

• Build and manage the supplier qualification program, including risk ranking, audits, scorecards, and Quality Agreements (QAAs).
• Approve suppliers and critical service providers; maintain the approved supplier list.
• Manage supplier changes/notifications and ensure impact assessments and Change Control are in place.
• Lead Supplier Corrective Action Requests (SCARs) and verify effectiveness; trend incoming defects and Certificate of Analysis (CoA) verification issues.
• Oversee the complaint intake/triage process; classify, open deviations, and assign investigations.
• Coordinate medical/clinical reviews as needed; escalate serious AEs and ensure timely regulatory reporting.
• Own the recall/field action Standard Operating Procedure (SOP) and maintain communication trees and regulator/customer contact lists.
• Lead customer audits and manage change notifications and customer-facing quality communications.

Qualifications

• BS/BA in a scientific field with 7–10+ years in Good Manufacturing Practice (GMP), including 5+ years in Supplier Quality and/or Post-Market/Complaints, preferably in a sterile/503B environment.
• Working knowledge of 21 CFR 210/211, 21 CFR Part 7 (recalls), 503B AE reporting expectations, and DSCSA/traceability basics.
• Leadership experience in customer/regulatory audits and at least one mock recall, preferably in a real field action.
• Proficient in technical writing, stakeholder management, and data analysis.

Benefits

• Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances).
• Health Benefits / Dental / Vision (Medix offers 6 different health plans: 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan. Eligibility for health benefits is based on verifying that an average of 30 hours per week during the first 4 weeks of the work assignment has been met. If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your assignment, depending on plan selection(s)).
• 401k (Eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1/1, 4/1, 7/1, and 10/1).
• Short Term Disability Insurance.
• Term Life Insurance Plan.

^*We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).

Medix Overview:

With over 20 years of experience connecting organizations with highly qualified professionals, Medix is a leading provider of workforce solutions for clients and candidates across the healthcare, scientific, technology, and government industries. Through our core purpose of positively impacting lives, we’re dedicated to creating opportunities for job seekers at some of the nation's top companies. As an award-winning career partner, Medix is committed to helping talent find fulfilling and meaningful work because our mission is to help you achieve yours.

^*As a job position within our Life Sciences division, a successful completion of a background check may be required as a condition of employment. This requirement is directly related to essential job functions including but not limited to: high-risk work environments (warehouse or industrial areas), high-risk/ high-error job duties that could result in life-threatening injury or death, operation of heavy-duty machinery, working with hazardous chemicals, exposure to other dangerous materials, such as drugs and sharp instruments. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.