Change Control Lead Quality Documentation SME

Spectraforce Technologies, Inc.; Branchburg Township (NJ); Sur place; USD 55 000 - 83 000; Plein temps

Résumé du poste

Spectraforce Technologies, Inc. is seeking a Documentation Specialist for an onsite 3-month assignment in Branchburg, NJ. The candidate will manage change controls in TrackWise and EDMS, guiding change initiators and acting as SME during audits.

Responsibilities include processing change requests, ensuring quality compliance, and mentoring team members in a fast-paced environment. Requires a Bachelor's degree and 5+ years in a documentation/quality role.

Qualifications

• Bachelor's degree in Business, Management or related discipline is required.
• Minimum of 5 years of experience within a documentation services group and/or Quality function utilizing a validated documentation management system and change management system (preferably TrackWise).
• Quality or change control experience with an understanding of medical device documentation (policies, procedures, work instructions, specifications, etc.).
• Experience supporting internal and external audits.
• Experience training change initiators as SME.
• Strong organizational and prioritization skills in a fast-paced environment.
• Strong written and oral communication skills.

Responsabilités

• Review, evaluate, and process complex high priority and business critical change requests.
• Provide guidance to change initiators as required.
• Evaluate and resolve quality issues related to change control.
• Complete processing of change requests and associated documentation.
• Identify potential process deficiencies and develop improvement solutions.
• Serve as SME for Quality Documentation and Change Control during regulatory audits.
• Assist Quality leadership with cross-functional teams and global initiatives; provide guidance to team members.

Connaissances

Strong organizational skills

Strong written and oral communication

Training SME

Multi-tasking in fast-paced env.

Formation

Bachelor's degree in Business, Management or related discipline

Outils

TrackWise

EDMS

Description du poste

Spectraforce Technologies, Inc. is seeking a Documentation Specialist for an onsite 3-month assignment in Branchburg, NJ. The candidate will manage change controls in TrackWise and EDMS, guiding change initiators and acting as SME during audits.

Responsibilities include processing change requests, ensuring quality compliance, and mentoring team members in a fast-paced environment. Requires a Bachelor's degree and 5+ years in a documentation/quality role.