Quality Systems Tech Lead, MedTech (Regulated)

Relha LLC; Raynham (MA); Hybrid; USD 102,000 - 204,000; Full time

Job summary

DePuy Synthes is seeking a Technology Manager, Quality Systems, BA, to lead the business analysis for validated quality platforms across Quality, Regulatory, and Manufacturing teams. You will manage a team of contributors, craft detailed requirements, user stories, and acceptance criteria, and drive implementation of CAPA, document management, and audit systems.

Required: 8+ years in regulated BA roles, 2+ years leadership, and experience with Veeva Vault QMS, TrackWise, or ETQ.

Qualifications

• Minimum 8 years of progressive experience in business analysis for regulated manufacturing/software environments.
• Minimum 2 years of experience leading teams and delivering results through others.
• Experience gathering and documenting requirements for enterprise quality management systems (Veeva Vault QMS, TrackWise, ETQ, Sparta or equivalent).
• Strong knowledge of GxP, 21 CFR Part 11, data integrity (ALCOA+) in requirements/design.

Responsibilities

• Directs requirements elicitation, analysis, and documentation across quality processes including complaint handling, CAPA, nonconformance, deviations, change control, document management, training, and audit management.
• Leads product functional design based on knowledge of quality system users, regulated processes, and platform capability.
• Maintains backlog for assigned quality platforms, balancing needs of Quality, Regulatory, Manufacturing, and Technology stakeholders.
• Translates business requirements into user stories, functional specs, acceptance criteria, and traceability matrices for a validated environment.
• Leads UAT strategy and execution, including test script authorship, defect triage, and go/no-go decisions.
• Ensures documentation satisfies computer system validation and change control obligations under 21 CFR Part 11 and data integrity requirements.
• Interfaces with ERP (SAP), PLM, and manufacturing platforms to define integration requirements.

Skills

Business analysis

Requirements elicitation

Regulated environment

User stories & specs

GxP & 21 CFR Part 11

Leadership

Education

Bachelor’s degree in Information Systems, Computer Science, Industrial Engineering, Life Sciences, Quality, Business, or related

Master’s in Information Systems or Business Administration

Tools

Veeva Vault QMS

TrackWise

ETQ

Job description

DePuy Synthes is seeking a Technology Manager, Quality Systems, BA, to lead the business analysis for validated quality platforms across Quality, Regulatory, and Manufacturing teams. You will manage a team of contributors, craft detailed requirements, user stories, and acceptance criteria, and drive implementation of CAPA, document management, and audit systems.

Required: 8+ years in regulated BA roles, 2+ years leadership, and experience with Veeva Vault QMS, TrackWise, or ETQ.