Compliance Specialist

Polymer Technology Systems, Inc • Whitestown, IN

59d • Hybrid

About The Position

The Compliance Specialist works with site process owners, CAPA assignees, and QA Reps to effectively manage implementation of corrective and preventive actions in a timely manner. They are responsible for ensuring timelines are met, documentation is complete and accurate, and problems are escalated as needed. Additionally, this position supports audits and audit scheduling.

Requirements

• Energetic, team-oriented, and strong communication skills
• Quality-focused, attentive to detail, and results-oriented
• Ability to identify root cause of a problem and creatively solve problems to gain resolution
• Bachelor's or Associate’s degree (or high school/GED +4 years of related work experience)
• Ability to communicate effectively (both written and oral) in English
• Ability to travel within US up to 10%
• Minimum 3 years’ experience in the medical device or pharmaceutical industry
• Minimum 3 years’ experience with CAPA systems, including complaint handling
• Minimum 3 years’ experience applying domestica and international regulations and standards (FDA QMSR, ISO 13485, IVDD/IVDR, etc.)

Nice To Haves

• Auditor certification a plus

Responsibilities

• Ensure regulatory compliance and optimization of quality management system procedures relating to CAPA through development, maintenance, and improvement of documented processes, development, implementation of employee training, and evaluation of competency of CAPA owners and QA Reps.
• Drive CAPA program activities, including working directly with CAPA owners to ensure compliance with regulatory requirements, the robustness of investigations / corrections / corrective and preventive actions, timely responses, and thoroughness of CAPA documentation.
• Identify and report any quality or compliance concerns and take immediate corrective action or escalate as required.
• Report appropriate data and metrics for review by Top Management.
• Provide direction and guidance to personnel across the organization to assist with their learning and effectiveness.
• Support gap analyses associated with changes to domestic and international regulations and standards.
• Support product and material NCR investigations, including evaluation for the need for corrective or preventive action.
• Support internal and external audits of the quality management system as well as audit scheduling.
• Additional duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree