Quality Assurance (Complaint & CA/PA) Specialist

Job Description

Job Description

Operates at the QA/RA staff level to execute and assure that complaints, corrective actions (CA), and preventive actions (PA) 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.
• Other duties as assigned.

Required Qualifications:
• Bachelor’s 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 and/or pharmaceutical quality management systems.
• Knowledge and experience in Internal QMS audit program and auditing.

Physical / Mental Demands:
• Working conditions are normal for an office environment.
• Work may require weekend and evening work.
• Work under stress in a fast-paced environment.
• Must be alert, able to concentrate, and use good judgment.
• Must be able to work under conditions that require sitting, standing, walking.
• Must be able to sit or stand throughout most of a shift with occasional walking.