Quality Management Systems Engineering Project Manager

Leads the design, implementation, and improvement of supplier quality controls and quality management system processes for regulated medical devices, software, and digital technologies.

Job Requirements

• Bachelor’s degree in engineering, quality, computer science, cybersecurity, software engineering, information systems, life sciences, or a related technical discipline

• Seven or more years of experience in quality systems, supplier quality, supplier controls, sourced device and material controls, regulatory compliance, or related quality functions within a regulated industry

• Experience assessing, designing, implementing, and improving quality management system processes

• Experience conducting supplier assessments and managing supplier lifecycle controls

• Experience developing supplier documentation, quality agreements, responsibility allocation matrices, and outsourced-process controls

• Experience supporting software suppliers, cloud service providers, technology suppliers, software-function medical device suppliers, component suppliers, original equipment manufacturers, and contract manufacturers

• Knowledge of risk-based supplier quality principles and quality system documentation

• Working knowledge of FDA 21 CFR Part 820 and the Quality Management System Regulation

• Working knowledge of ISO 13485:2016 supplier, purchasing, and outsourced-process requirements

• Working knowledge of ISO 14971 medical device risk management requirements

• Knowledge of FDA inspection and Medical Device Single Audit Program expectations

• Knowledge of 21 CFR Part 11 electronic records and electronic signature requirements

• Knowledge of FDA Computer Software Assurance principles

• Knowledge of applicable FDA post-market requirements

Preferred Skills

• Knowledge of European Union Medical Device Regulation and In Vitro Diagnostic Regulation requirements

• Knowledge of IEC 62304 medical device software lifecycle requirements

• Knowledge of IEC 82304-1 health software product safety requirements

• Knowledge of IEC 81001-5-1 health software cybersecurity lifecycle requirements

• Knowledge of FDA software and cybersecurity guidance

• Knowledge of International Medical Device Regulators Forum Software as a Medical Device guidance

• Familiarity with artificial intelligence and machine-learning regulatory frameworks

• Familiarity with artificial intelligence and machine-learning risk-management methods

• Experience developing quality controls for cloud-based, connected, or digitally enabled medical products

• Experience supporting emerging digital health technologies

Job Responsibilities

• Assess and improve supplier quality and quality management system processes

• Develop risk-based supplier qualification, assessment, approval, monitoring, and re-evaluation procedures

• Establish supplier controls for software, cloud services, components, finished devices, and outsourced manufacturing processes

• Conduct supplier assessments and document supplier quality risks

• Develop and maintain supplier quality agreements

• Create responsibility allocation matrices defining quality and regulatory obligations

• Establish controls for outsourced processes and externally provided products and services

• Review supplier quality documentation for compliance with regulatory and quality-system requirements

• Define supplier classification, oversight, monitoring, and escalation criteria

• Support supplier onboarding, lifecycle management, performance monitoring, and remediation

• Evaluate quality controls for software and technology service providers

• Apply risk-management principles to supplier and outsourced-process decisions

• Support FDA inspections, MDSAP audits, and other regulatory assessments

• Ensure supplier controls align with FDA, ISO 13485, ISO 14971, and applicable international requirements

• Support compliance with electronic record, software assurance, cybersecurity, and post-market requirements

• Identify quality-system gaps and implement corrective or preventive improvements

• Develop procedures, work instructions, templates, and supporting QMS documentation

• Monitor regulatory and standards changes affecting supplier quality, software, cybersecurity, and digital health products

• Support quality-system frameworks for artificial intelligence, machine learning, and emerging digital technologies

Pay: 55-62/hr

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client.

Pay Details: $55.00 to $62.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

To read our Candidate Privacy Information Statement, which explains how we will use your information, please

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.