The Manager Quality Operations is responsible for leading and managing all aspects of Quality Operations, including Quality Control (QC) and Product Release, Supplier Quality Engineering (SQE), and oversight of Contract Manufacturing Organizations (CMOs) and key suppliers, including distributors. This role ensures that products are manufactured and released in full compliance with applicable quality and regulatory standards. The Manager Quality Operations leads a team of Quality Engineers and Quality Technicians, and holds the authority for product release.

Responsibilities

Quality Operations:

• Oversee and manage day-to-day quality activities across internal operations and external manufacturing partners (CMOs).
• Ensure that all manufacturing and assembly activities, both internal and outsourced, are conducted in accordance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulations.
• Review and approve Device History Records (DHRs), lot release documentation, and Certificates of Analysis/Conformance from suppliers and CMOs.
• Support quality oversight of technology transfers, process validations, and change control involving CMOs and suppliers.
• Collaborate cross-functionally with Procurement, Supply Chain, R&D, and Manufacturing to ensure production quality and regulatory compliance.
• Manage quality operations processes including deviations, nonconformances, and CAPAs related to production and incoming materials.

Quality Control (QC):

• Supervise inspection and testing of incoming materials, in-process components, and final products.
• Ensure testing protocols are validated and consistently followed.
• Analyze trends from inspection data and initiate quality improvements as needed.
• Act as primary backup for Quality Control activities

Supplier Quality Engineering (SQE):

• Qualify, audit, and monitor suppliers, distributors and CMOs to ensure compliance with Onward Medical’s quality standards.
• Establish and maintain Quality Agreements, define inspection criteria, and evaluate supplier performance metrics.
• Manage and assess Supplier Change Requests to ensure appropriate risk evaluation, documentation, and approval before implementation.
• Lead investigations into supplier-related nonconformances, ensuring effective root cause analysis and implementation of corrective actions.
• In collaboration with Purchasing department, actively lead supplier development initiatives by establishing structured performance management frameworks, fostering strategic partnerships, and driving continuous improvement

Product Release Authority:

• Act as the final quality approver for product release, ensuring compliance with product specifications, quality records, and applicable regulations.
• Sign off on batch release documentation and contribute to regulatory submissions as needed.
• Act as primary backup for Product Release activities.
• Serve as backup for the final quality approval of product releases conducted at other Onward manufacturing sites.

Experience, Qualifications & Skills

• Master’s degree in Engineering, Life Sciences, or related discipline.
• Minimum 8 years of experience in Quality roles within the electromechanical medical device industry, with at least 3 years in a leadership capacity.
• Proven experience managing CMOs and suppliers in a regulated environment.
• Solid understanding of ISO 13485, FDA 21 CFR Part 820, and related regulatory frameworks.
• Hands-on experience with Supplier Change Request (SCR) processes, CAPA, risk management, and process validation.
• Proficiency with quality tools (e.g., 8D, FMEA, SPC).
• Excellent communication, collaboration, and leadership skills.
• Fluent in English; other languages are a plus.

Supervision

• Lead, mentor, and support a team of Quality Engineers and Quality Technicians.
• Allocate tasks and resources to meet department goals and production deadlines.
• Foster a proactive, quality-focused culture throughout the organization.