QMS Integration Specialist - Remote

Pay Rate: $58.00/hr.

Duration: 18 Months, contract only

Location: Remote (EST time zone working hours)

Position Summary

The QMS Integration Specialist / RAQA Technical Writer will support the integration of products and quality processes into the Stryker Quality Management System (QMS). This role will partner closely with RAQA, Quality, Operations, Engineering, and other subject matter experts to assess existing processes and documentation, identify gaps against the future-state QMS, and develop or revise controlled documentation required to successfully implement the integrated quality system.

The position requires a combination of QMS knowledge, process analysis, technical writing, and project execution skills, with particular emphasis on converting complex quality and regulatory requirements into clear, compliant, and user-friendly procedures, work instructions, forms, process maps, and supporting documentation.

Key Responsibilities

QMS Integration and Gap Assessment

• Perform detailed assessments of existing procedures, processes, records, and supporting documentation against Stryker requirements.
• Support procedure-by-procedure applicability assessments and recommend whether documentation should be adopted, harmonized, revised or remediated, retained, or retired.
• Identify documentation and process gaps, dependencies, risks, and implementation actions.
• Support development of the future-state process model and transition from legacy processes to the applicable QMS.
• Maintain traceability between current-state documentation, future-state requirements, identified gaps, and resulting actions.

Technical Writing and Documentation

• Draft or revise controlled QMS documentation, including SOPs, work instructions, forms, templates, process maps, workflows, and supporting quality documents.
• Translate input from subject matter experts and process owners into clear, concise, and compliant documentation.
• Facilitate document review cycles and incorporate stakeholder feedback.
• Ensure consistency in terminology, structure, formatting, roles, responsibilities, and process interfaces.
• Develop and maintain document history and change records.

Document Control and QMS Implementation

• Support controlled document creation, revision, approval, implementation, and retirement activities.
• Support mapping and disposition of quality records as part of the QMS transition.
• Coordinate documentation activities with training and implementation plans to ensure revised processes are effectively deployed.
• Support documentation readiness for audits, inspections, and QMS transition activities.
• Assist with tracking integration actions, documentation status, decisions, risks, and closure evidence.

Qualifications

Required

• Bachelor's degree in Engineering, Life Sciences, Technical Communication, or a related discipline, or equivalent relevant experience.
• 3+ years of experience in Quality Systems, QMS technical writing, or documentation within a regulated industry.
• Demonstrated experience writing and revising SOPs, work instructions, forms, and other controlled QMS documentation.
• Working knowledge of Quality Management Systems and regulated documentation practices.
• Demonstrated ability to evaluate existing processes, identify gaps, and translate requirements into practical documentation.
• Strong technical writing, editing, organization, and communication skills.
• Ability to facilitate discussions with subject matter experts and interact independently to drive documentation to completion.
• Ability to manage multiple documents, actions, and priorities in a project-based environment.

Preferred

• Experience in the medical device industry.
• Knowledge of ISO 13485 and applicable medical-device quality-system requirements.
• Experience supporting QMS integrations, acquisitions, site transfers, or quality-system harmonization.
• Experience with electronic QMS and document-management platforms such as MasterControl and/or TrackWise.
• Experience developing process maps and performing procedure or QMS gap assessments.

Experience working with cross-functional or geographically distributed integration teams.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.