Randstad Sourceright Hiring! Full Time QMS Separation - Quality Specialist in Selangor - Ricebowl

Role Purpose:

• Project Osprey is Johnson & Johnson’s strategic initiative to separate its Orthopaedics business, establishing DePuy Synthes as a standalone organization to drive focused growth, operational agility, and innovation. 

• The QMS Separation & Quality Specialist will support and assist the SEA Osprey Lead in the execution and coordination of all quality-related activities required for the Osprey QMS separation, in line with the Project Plan and Quality Plans.

• This role is focused on hands-on execution, coordination, and tracking of defined QMS separation activities to ensure the effective separation, transition, and sustainment of Quality Management System (QMS) processes, documentation, and records, while maintaining alignment with applicable regulatory, corporate, and internal quality requirements.

• This role exists to assist the Lead in ensuring all QMS separation activities are delivered accurately, consistently, and on time, in accordance with the established plan.

• The role will work closely with SEA Quality, Operations, supply chain, Regulatory, and Facilities teams, and will engage with Regional and Global Quality stakeholders as required to support a smooth and compliant QMS separation.

Key responsibilities:

QMS Separation Execution & Coordination

• Execute and coordinate assigned QMS separation activities for the Osprey program in accordance with the approved Project Plan and Quality Plans.

• Track progress of quality-related separation activities and support the SEA Osprey Lead by identifying dependencies, risks, or delays requiring attention or escalation.

• Support execution of the creation, revision, migration, and retirement of QMS documentation required for the separation.

• Assist with implementation activities to support continuity and effectiveness of quality processes during transition and post-separation steady state.

• Assist in preparation for company certification to GDPMD, ISO13485:2016 and other inspection relevant to the separation.

Quality System Management

• Execute and track assigned change management activities (CRs, CNs, Tasks) related to QMS separation.

• Support accurate maintenance, organisation, and segregation of quality records, logs, and registers within EtQ, Windchill, and other approved systems.

Quality Management System certification – Specific  for SEA

• Participate in the Quality Management System (QMS) certification process and perform assigned tasks related to document development and revision, inspection readiness, and inspection management.

Risk & Compliance Support

• Support visibility of quality risks associated with QMS separation execution, escalating concerns to the SEA Osprey Lead as defined by governance processes.

• Support adherence to applicable regulatory, corporate, and internal quality requirements during execution of separation activities.

Quality Records Management & Metrics

• Support identification, segregation, and traceability of quality records as part of the QMS separation, ensuring records are clearly organised and retrievable.

• Support clear segregation of J&J and new DePuy LE quality data to enable accurate and compliant metric reporting.

• Maintain visibility of record completeness and data integrity, escalating gaps or inconsistencies to the SEA Osprey Lead where required.

Stakeholder & Communication Management

• Act as a key execution and coordination support resource to the SEAOsprey Lead across SEA Quality, Operations, supply chain /deliver Regulatory, and Facilities teams.

• Support coordination with Regional and Global Quality stakeholders to align timelines, deliverables, and execution expectations.

• Provide regular execution status updates and highlight risks, dependencies, or issues impacting delivery.

• Support communication and user guidance related to separated or transitioned QMS processes, as required.

Others:  

• Accept assignment from SEA Osprey lead.
  

Requirements:

• Bachelor’s degree in Quality, Science, Engineering, Healthcare, Life Sciences, or a related discipline OR

• At least 3 years experience working within a Quality Management System (QMS) in a regulated health care or medical devices industry 

• Hands-on experience with EtQ, Windchill, Summit/Compliancewire, complaint management or similar electronic QMS platforms.

• Strong project management, coordination and stakeholder communication skills.

• Strong technical writing in quality plan, procedures, work instruction and operational protocol. 

• Proficient in MS Offices suites such as PowerPoint and Excel