Project Manager - Dorado

Integrated Services for Productivity & Validation, Inc; Dorado (PR); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading medical device company is seeking an experienced professional to lead strategic projects and manage cross-functional teams. The ideal candidate should have 5–7+ years in manufacturing or quality engineering within an FDA-regulated industry. Responsibilities include ensuring product quality, compliance, and overseeing new product initiatives. Strong knowledge of FDA regulations and process validation is required. This role offers opportunities for growth and impact within a dynamic organization.

Qualifications

• 5–7+ years of experience in manufacturing engineering or quality engineering within an FDA-regulated industry.
• Strong knowledge of FDA Quality System Regulation (21 CFR Part 820) and Good Manufacturing Practices (GMP).
• Experience with risk management and root cause investigations.

Responsibilities

• Provide leadership in strategic projects with site impact.
• Manage cross-functional teams for new product development.
• Ensure compliance with quality policies and project lifecycle.

Skills

Manufacturing engineering experience

Quality engineering knowledge

FDA Quality System Regulation knowledge

Collaboration skills

Job description

Job Description

• Provide vision and leadership to strategic projects with significant site impact.
• Ensure new products are launched from the site in alignment with contract goals.
• Manage the performance of projects or significant subsystems associated with new products by influencing, coordinating, and driving activities, initiatives, and development deliverables across cross-functional teams.
• Direct all phases of new product development projects from inception through completion from an Operations perspective.
• Lead project review sessions focusing on cost, schedule, and technical performance.
• Establish milestones, monitor adherence to plans and schedules, identify issues, and implement solutions.
• Demonstrate strong leadership, clear communication, and the ability to build effective cross-functional working relationships.
• Ensure Value Improvement Projects (VIP) and new product initiatives are completed in alignment with contract expectations.

Key Responsibilities

• Project Planning & Definition: Define project goals, scope, resource and cost estimates, timeline, and risks. Facilitate cross-functional discussions to develop project proposals.
• People Leadership: Manage large, multi-project, multi-site cross-functional teams; provide performance input; foster strong alignment.
• Value Improvement (VIP): Oversee VIP initiatives; identify, communicate, and manage risks.
• Project / Program Management: Lead initiation, planning, execution, control, and close-out activities; ensure team ownership of plans, schedules, and budgets.
• Process Management: Ensure activities follow established processes; maintain documentation discipline; reinforce VIP and NPE best practices.
• Communications & Reviews: Drive cross-functional communication; serve as liaison between teams and leadership; lead phase reviews; maintain documentation including minutes, issue logs, and metrics.
• New Product Excellence (NPE): Implement NPE methods; manage NPE risks and deliverables.

Quality System Requirements

Demonstrate a primary commitment to patient safety and product quality by adhering to applicable quality policies, procedures, and requirements.

For roles with direct reports: Ensure adequate resources (personnel, tools, etc.) are in place to support quality compliance and promote a work environment aligned with quality expectations.

Job Scope & Leveling Guidelines

• Functional Knowledge: Applies in-depth conceptual, practical, and technical knowledge; understands related functions.
• Business Expertise: Applies knowledge of key business drivers and cross-team integration to achieve objectives.
• Leadership: Provides guidance, coaching, and may lead smaller projects or sub-projects with manageable risk.
• Problem Solving: Solves problems of varying complexity; adapts or develops solutions using judgment and experience.
• Impact: Influences project, operational, or service activity effectiveness.
• Interactions: Communicates complex information clearly; persuades and guides stakeholders in cross-functional settings.

Requirements

• 5–7+ years of experience in manufacturing engineering or quality engineering within an FDA-regulated industry (medical devices, pharmaceuticals, biotechnology, diagnostics, or similar).
• Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), Good Manufacturing Practices (GMP), and ISO 13485.
• Experience supporting new product introductions (NPI/NPD), including process development, equipment qualification, and process validation.
• Hands-on experience with risk management (FMEA, hazard analysis), root cause investigations, and CAPA systems.
• Proven collaboration with Operations, Quality Assurance, Regulatory, R&D, and Supply Chain teams.
• Familiarity with controlled documentation systems, engineering change processes, and manufacturing readiness requirements.
• Experience ensuring compliance with quality system procedures and regulatory expectations across the project lifecycle.