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.
qualifications:
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.
- Advanced degree and Lean Six Sigma certification.
- Experience with validated systems, digital tool governance, or AI governance in medical products.
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.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
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.
