R&D Document Control Lead — PLM & Compliance

Teleflex; Maple Grove (MN); On-site; USD 101,000 - 151,000; Full time

Benefits offered by this job

Medical insurance

401(k) savings plan

Paid time off

Disability and parental leave

Job summary

Teleflex is seeking a Senior R&D Document Specialist to serve as the subject matter expert for document control, PLM, and engineering change processes. You will drive accuracy, compliance, and timely release of product documentation, partnering with Engineering, Quality, Regulatory, Manufacturing, and Supply Chain across the product lifecycle.

The role focuses on leading ECO/CO workflows, ensuring DHF readiness, and implementing process improvements in PLM, ERP, and QMS environments to support

Qualifications

• Bachelor's degree in Engineering, Science, Technical Communications, or related discipline preferred.
• Minimum of 5 years of experience in engineering document control, PLM, engineering change management, or related functions within a regulated medical device environment.
• Experience using PLM, ERP, and Quality Management Systems (Oracle Agile, SAP S/4HANA/MDG, Windchill, Arena, or equivalent).

Responsibilities

• Serve as the R&D SME for document control, engineering change management, and PLM processes.
• Lead and facilitate ECO/CO workflows, ensuring complete, compliant documentation.
• Ensure documents comply with FDA, ISO 13485, MDR, and internal Quality System requirements.
• Partner with cross-functional teams to develop and release DHF documentation for new product development and sustaining engineering.
• Identify and implement best practices in document control and drive process improvements.

Skills

Documentation control

Attention to detail

Quality compliance

Cross-functional collaboration

Influence without authority

Education

Bachelor's degree in Engineering/Science/Technical Communications

Tools

Oracle Agile

SAP S/4HANA/MDG

Windchill

Arena

Job description

Teleflex is seeking a Senior R&D Document Specialist to serve as the subject matter expert for document control, PLM, and engineering change processes. You will drive accuracy, compliance, and timely release of product documentation, partnering with Engineering, Quality, Regulatory, Manufacturing, and Supply Chain across the product lifecycle.

The role focuses on leading ECO/CO workflows, ensuring DHF readiness, and implementing process improvements in PLM, ERP, and QMS environments to support