Quality Systems Program Manager

Job Description

Job Roles & Responsibilities

Provide oversight for the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance with internal policies and external standards / regulations.

Offer expertise and guidance in interpreting company policies, governmental regulations, and internal procedures to assure compliance.

Work directly with operating entities to provide ongoing process analysis and enforce compliance requirements.

Lead audit and inspection preparation, manage resolution of findings, and liaise with auditors and inspectors through all audit stages.

Prepare reports and documentation (e.g., Corrective and Preventative Actions) for both internal and external stakeholders.

Coordinate legal requests in support of government investigations or litigations.

Maintain and regularly update quality assurance programs and policies, ensuring alignment with best practices and global standards.

Facilitate uniform standards worldwide to support the achievement of the company’s mission.

Provide input on establishing program objectives, timelines, milestones, and budgets.

Recommend new policies and procedures that improve program management and compliance.

Monitor program performance, customer satisfaction, and drive continuous improvements.

Communicate and lead meetings with internal / external customers and vendors, presenting briefings to higher management.

Solve issues through influence, information exchange, and persuasion across program execution teams.

Directly involved in daily tasks necessary for program execution.

Project Goals

Drive successful project execution for medical devices with emphasis on safety, compliance, and quality.

Ensure timely delivery of program objectives within scope, schedule, and cost guidance.

Improve program management processes for efficiency, innovation, and compliance.

Foster cross-functional collaboration and knowledge sharing to enhance global program effectiveness.

• Other duties may be assigned

Requirements

Experience

Minimum 5+ years of experience in medical device design, development, and / or manufacturing (experience with products containing electrical functionality is an advantage).

Proven track record of leading cross-functional teams using project management methodologies (planning, communication, risk management).

Top Qualifications

Hands-on experience managing projects and scheduling in medical device manufacturing.

Strong negotiation and communication skills.

Proven ability in risk management and critical thinking.

Conflict resolution skills.

Knowledge of medical device regulations.

Technical Skills (Must Have)

Medical device design, development, and manufacturing experience.

Examples of critical thinking and proven project execution.

Ability to lead and collaborate respectfully across functions to drive execution.

Strong project management skills : planning, communication, risk management.

Knowledge of Quality Management System (QMS) documents and compliance.

Proficiency in scientific problem-solving methodologies (DMAIC, process mapping, 5 Whys, Is / Is Not, etc.).

Strong decision-making ability, accuracy, and attention to detail.

Capability to prioritize, identify critical paths, track progress, and escalate challenges early.

Education

Bachelor’s degree in Engineering or Sciences.