Quality Specialist, Complaint & CA​/PA

Operates at the QA/RA staff level to execute and assure that complaints, Corrective Actions, and Preventive Actions are being actively addressed in a timely manner. Supports day‑to‑day QA and QC activities as assigned by their direct supervisor, including Device History Record completion and product release. Back‑up for calibration and equipment maintenance for QC Lab. Direct involvement with the Internal Audit program.

Provides supporting activities as assigned for ongoing projects, including but not limited to Gauge R&Rs, Process Validations, and Software Validations.

• Primary contact and initial owner of Customer Feedback (Complaints, inquiries). Responsible for the evaluation and, if necessary, initial investigation for Customer Feedback issues.
• Approver of Customer Feedback documents when submitted for approval if assigned.
• Initial owner or creator of Corrective Actions and Preventive Actions.
• Oversight and functional subject matter expert for top‑level QMS, such as document control and other quality systems.
• Provide support to the Internal and Supplier Audit programs, such that IMI remains compliant with Regulatory registrations and certifications.
• Ownership and/or participation in monthly QA/QC Trend Pareto Charts.
• Provide support to the Calibration Program, Non‑Conforming Product Reports, and other Quality processes as needed.

• 4‑year University degree in science, math, business, or related field.
• 3 years of experience as a Quality Assurance professional for medical devices sold within the US.
• Must be able to read, write, and speak the English language and be understood.
• Strong and effective communication skills.
• Able to work independently with limited supervision.
• In‑depth knowledge of ISO 13485 and 21 CFR Part 820.
• Familiar with the workings and responsibilities of the Notified Body, Authorized Representative, and Competent Authority in the EU and MDSAP countries.
• Working knowledge of the MDSAP program, MDSAP Audits, and its relationship to Competent Authorities.

• Certified Quality Auditor (CQA), Certified Six Sigma Yellow Belt (CSSYB), or comparable certification.
• 5 Years of experience in medical devices or pharmaceutical Quality Management Systems.
• Knowledge and experience in Internal QMS audit program and auditing.

• Must sit for long periods of time in an office chair.
• Minimal lifting, up to 50 lbs.
• Normal office environment, subject to heat, cold, or weather for short periods when visiting sites or suppliers.

Mid‑Senior level

Full‑time

Quality Assurance

Medical Equipment Manufacturing

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