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Quality Specialist
Contract: Roseville, California, US
Salary Range: 45.00 - 50.00 | Per Hour
Job Code: 362033
End Date: 2025-06-14
Days Left: 4 days, 23 hours left
Position Details:
Industry Medical Devices
Job Title Senior Quality Systems Specialist
Work Location Virtual California - 100% Remote
Duration 24+ months
Pay Range $45-50/hr
Job Description:
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Responsibilities may include the following and other duties may be assigned: Collaborate with end-users, subject matter experts (SMEs), and project stakeholders across different functional areas (Engineering, Manufacturing, Quality, Regulatory) and site locations.
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Support interviews, workshops, and reviews of existing documentation to thoroughly understand and translate current PLM-related business processes ("as-is") for approval by customers and downstream consumption by the core design team and stakeholders.
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Identify opportunities for consolidation of duplicative/overlapping documents and common processes, and support QMS Standardization efforts where needed.
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Create clear, concise, and accurate process flow diagrams (using tools like Visio, Lucidchart, etc.) and narratives of current state operations.
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Work with the implementation team and SMEs to understand the defined future state processes within Windchill.
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Document the future state ("to-be") process flows, clearly illustrating how tasks currently performed in the legacy system will be accomplished in Windchill.
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Map the relationships and transformations between "as-is" and "to-be" processes, highlighting key changes for users.
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Support the development of training materials and communication plans by providing clear process documentation.
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Maintain organized documentation repositories for easy access and review.
Must Have (Minimum Requirements)
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Bachelor's degree in Business Administration, Information Systems, Engineering, or a related field.
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3-5 years of experience in a Business Process Analyst, Process Analyst, or similar role involving process documentation and mapping.
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Proven experience working with Product Lifecycle Management (PLM) systems.
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Demonstrated proficiency in process mapping methodologies and tools (e.g., Visio, Lucidchart, BPMN).
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Excellent interviewing and requirements gathering skills.
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Strong written and verbal communication skills, with the ability to translate technical concepts into clear business process documentation.
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High attention to detail and commitment to accuracy.
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Ability to work effectively both independently and as part of a cross-functional team.
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Strong organizational and time management skills.
Nice to Have (Preferred Qualifications)
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Direct hands-on experience with PTC Windchill PLM.
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Experience working within a regulated industry (Medical Device, Pharmaceutical, Aerospace, Automotive) and familiarity with associated quality systems (e.g., QMS, ISO 13485, GxP).
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Experience participating in large-scale system implementation projects (ERP, PLM, MES).
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Familiarity with core PLM concepts such as Document Management, Change Management, Bill of Materials (BOM) Management.
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This position reports to the PLM Process Lead.
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Ability to travel: Minimal, up to 10%
Job Requirement
- quality system
- process mapping
- Product lifecycle
- regulated industry
Reach Out to a Recruiter
- Recruiter
- Phone
- Srividhya M
- srividhya.m@collabera.com
Apply Now
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