Senior Consultant, Product Delivery Excellence & R&D Process Simplification

Randstad USA; Batesville (IN); On-site; USD 124,000 - 142,000; Part time

Job summary

Randstad USA in Batesville, Indiana seeks a Senior Consultant on a 12-month contract to drive end-to-end Product Delivery Excellence (PDE) and Quality Management System (QMS) workflows. You will lead high-visibility process transformations, align cross-functional ownership, and implement governed AI tools to accelerate speed, quality, and regulatory compliance.

The role requires 15+ years in medical device product development, design controls, and quality systems, with Lean/Six Sigma expertise.

Qualifications

• Bachelor's degree in Engineering, Science, Quality, Operations, Business or related field.
• 15+ years of experience in medical device product development, design controls, change control, and quality systems (FDA QSR, ISO 13485).
• Proven mastery in Lean, Six Sigma, value-stream mapping, or equivalent process optimization methodologies.
• Practical experience applying AI or automation tools to regulated business or technical workflows.

Responsibilities

• Map current PDE and QMS processes to establish baseline cycle times, rework, and pain points across R&D.
• Create and maintain a prioritized process simplification roadmap based on value, compliance risk, and effort reduction.
• Redesign high-priority workflows to eliminate redundant steps and duplicate documentation while maintaining patient safety and regulatory standards.
• Collaborate with Quality and Regulatory partners to align procedures and decision rights prior to piloting and rollout.
• Identify, prioritize, and deploy practical AI and automation use cases for document drafting, data preparation, and knowledge retrieval with governance.
• Establish metrics, conduct pilots, create job aids/training materials, and transition ownership for long-term sustainability.

Skills

Project Management

MS-Project

Six Sigma Methodologies

Quality Management Systems

Education

Bachelor's Degree

Tools

MS-Project

Job description

job summary: Are you a continuous improvement leader ready to drive high-visibility process transformation in medical device R&D? A premier medical technology leader in Batesville, IN is seeking a Senior Consultant for a 12-month engagement to streamline end-to-end Product Delivery Excellence (PDE) and Quality Management System (QMS) workflows. In this strategic role, you will reduce process burden, align cross-functional ownership, and implement governed AI tools to accelerate speed, quality, and regulatory compliance.

location: Batesville, Indiana

job type: Contract

salary: $90.00 - 103.07 per hour

work hours: 9 to 5

education: Bachelors

Responsibilities

• Map current-state PDE and QMS processes to establish baseline cycle times, rework, and pain points across R&D.
• Create and maintain a prioritized process simplification roadmap based on business value, compliance risk, and effort reduction.
• Redesign high-priority workflows to eliminate redundant steps and duplicate documentation while maintaining patient safety and regulatory standards.
• Collaborate with Quality and Regulatory partners to align procedures and decision rights prior to piloting and rollout.
• Identify, prioritize, and deploy practical AI and automation use cases for document drafting, data preparation, and knowledge retrieval with proper governance.
• Establish metrics, conduct pilots, create job aids/training materials, and transition ownership for long-term sustainability.

Required

• Bachelor's degree in Engineering, Science, Quality, Operations, Business, or a related field.
• 15+ years of experience in medical device product development, design controls, change control, and quality systems (FDA QSR, ISO 13485).
• Proven mastery in Lean, Six Sigma, value-stream mapping, or equivalent process optimization methodologies.
• Practical experience applying AI or automation tools to regulated business or technical workflows.

Preferred

• Advanced degree and Lean Six Sigma certification.
• Experience with validated systems, digital tool governance, or AI governance in medical products.

Skills

skills: Project Management, MS-Project, Six Sigma Methodologies, Quality Management Systems (QMS)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.