Website Oxenham Group LLC
Oxenham Group LLC
Company : Oxenham Group LLC
Overview
The Quality Operations Manager is a senior people leader responsible for day to day execution of the Quality Management System within a contract manufacturing environment. This role owns quality operations on the floor and across functional interfaces, ensuring compliance with ISO 13485 and customer requirements while building a disciplined, accountable, and engaged quality organization.
This leader will manage and develop a team of Quality Supervisors, Inspectors, Engineers, and Technicians and will serve as a key partner to Manufacturing, Engineering, and Customer teams.
Key Responsibilities
" Lead and develop a multi level Quality organization including supervisors, inspectors, engineers, and technicians
" Own execution of the ISO 13485 compliant Quality Management System within daily operations
" Ensure effective oversight of incoming, in process, and final inspection activities
" Drive disciplined execution of nonconformance management, CAPA, deviation handling, and root cause investigations
" Partner closely with Manufacturing and Engineering to resolve quality issues and prevent recurrence
" Ensure inspection, testing, and release activities support production flow without compromising compliance
" Serve as a primary quality interface for customers, audits, and quality related communications
" Lead internal audits, support customer audits, and ensure audit readiness at all times
" Establish clear expectations, metrics, and accountability across the Quality team
" Build a culture of ownership, learning, and continuous improvement within Quality Operations
People Leadership Responsibilities
" Directly manage Quality Supervisors and senior individual contributors
" Coach and develop inspectors, engineers, and technicians at varying experience levels
" Set clear standards for performance, decision making, and escalation
" Address performance gaps with clarity and consistency
" Build bench strength and succession within the Quality organization
Required Skills and Experience
" Seven plus years of quality experience in a medical device, life sciences, or CMO environment
" Proven people leadership experience managing supervisors and front line quality teams
" Deep working knowledge of ISO 13485 and FDA QSR expectations
" Hands on experience with inspections, nonconformances, CAPA, and change control
" Strong understanding of manufacturing processes and production driven quality challenges
" Ability to balance compliance rigor with operational execution
" Clear, confident communicator with the ability to engage operators, leaders, and customers
Preferred Qualifications
" Experience supporting multiple customers within a contract manufacturing environment
" Background working through quality remediation, scaling operations, or customer escalations
" Familiarity with continuous improvement tools and data driven quality metrics
Why This Role Matters
This position is central to protecting customer trust, ensuring compliance, and enabling reliable manufacturing execution. The Quality Operations Manager sets the tone for how quality shows up on the floor every day and plays a direct role in customer satisfaction, audit outcomes, and long term growth.