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.