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.

Duties and Responsibilities:

· 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.

Required Qualifications:

· 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.

Preferred Qualifications:

· 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.

Physical/Mental Demands:

· 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.