E-QMS Business Partner​/PM; Oracle ERP-Medical Device Industry

e-QMS Business Partner/PM (Oracle ERP-Medical Device Industry)

Next Phase.ai is a Data Management solution provider specializing in Data Operations services for enterprise cloud data, helping clients enhance data quality, strengthen governance, and achieve strategic business outcomes. As we expand into digital manufacturing and regulated industries such as medical devices, we continue to deliver innovative, high-value solutions that enable clients to focus on monetizing and scaling their data while we manage the complexity behind the scenes.

We offer a dynamic, collaborative, and creative work environment where solving client challenges with smart, data‑driven thinking is at the heart of what we do.

Overview

We are seeking an experienced e‑QMS Business Partner / Project Manager with strong expertise in Oracle ERP (EBS or Cloud) and a deep understanding of quality processes within the medical device industry
. The ideal candidate will be a hands‑on leader capable of driving system implementations, aligning cross‑functional teams, and ensuring that e‑QMS and Oracle ERP integrations meet strict regulatory and business requirements. This role requires someone who can take ownership, lead with confidence, and deliver a scalable global quality and ERP solution.

Key Responsibilities:

• Lead the implementation of the e‑QMS platform and coordinate alignment with key Oracle ERP modules (Quality, Manufacturing, SCM, Procurement, and Document Control).
• Partner closely with Quality, Manufacturing, Supply Chain, and IT to manage functional dependencies and ensure seamless system integration.
• Translate paper‑based and legacy processes into digitized workflows, supporting high‑volume change management (e.g., 300+ MCRs/month).
• Conduct workshops, requirement‑gathering sessions, and detailed design meetings; provide granular guidance to internal teams and external consultants.
• Develop and maintain a global systems architecture supporting multi‑site manufacturing operations and medical device compliance (ISO 13485, 21 CFR Part 820).
• Drive proactive communication with vendors, Oracle partners, and stakeholders to ensure flexibility, alignment, and timely execution.
• Lead cross‑functional teams, anticipate risks, and maintain momentum throughout project cycles.

Required Qualifications:

• Proven experience implementing e‑QMS systems and integrating them with Oracle EBS or Oracle Cloud ERP
  .
• Strong understanding of medical device quality processes
  , including CAPA, NCR, Document Control, Training, Audit, and Change Management.
• Hands‑on expertise in ERP‑Quality integration points and business process mapping.
• Demonstrated ability to collaborate effectively with Quality, IT, Operations, Supply Chain, and Finance teams.
• Strong project management and organizational skills to handle complex, multi‑module implementations.
• Experience supporting or designing global ERP and QMS architectures for regulated manufacturing environments.
• Excellent vendor management, communication, and stakeholder‑alignment skills.
• Proactive, solutions‑oriented approach to issue resolution and cross‑functional coordination.

Preferred Qualifications:

• Experience automating manufacturing and quality processes within Oracle ERP and integrating with MES, PLM, or LIMS systems.
• Background in global manufacturing expansion, multi‑site rollouts, and regulatory compliance in the medical device industry.
• Strong business acumen with the ability to drive decisions, influence teams, and anticipate challenges ahead of time.

Soft Skills:

• Ability to work effectively across teams and navigate complex, regulated environments.
• Strong interpersonal skills with the ability to build trust, collaborate, and drive project execution.
• Excellent problem‑solving skills and the ability to resolve issues proactively.
• Adaptable, flexible, and capable of stepping out of comfort zones to lead cross‑functional efforts.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship or employment visas currently.

Next Phase.ai is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.