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Sr. Quality Engineer is a direct contributor and owner of tasks within the Quality Management system. Including but not limited to: NCs/CAPAs/Complaint investigations, validation support, audit support etc.

The Senior Quality Engineer is responsible for implementation maintenance of the Rebound Therapeutics quality management system in accordance with 21 CFR Part 820, ISO 13485, MOD 93/42/EEC, ISO 14971. The Senior Quality

Engineer will assist in maintenance of the Quality Management System. The

Senior Quality Engineer may also assist during external audits from the FDA, FOB and Notified Body. The Senior Quality Engineer may also conduct vendor audits as required.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

• Initiates DCOs to update, correct and streamline documents in the QMS and for the manufacturing process.

• Suggests, implements projects to streamline product manufacturing and the QMS

• Works with QC to improve inspections, documentation. Develops workmanships standards for the product including development of Work Instructions (CWls).

• Works with suppliers on resolving non-conformances in raw material components, refining specifications, documentation, etc.

• Manages supplier files including approval, review, re-evaluation etc.

• Manages non-conforming material reports and makes suggestions for disposition, correction, corrective actions, verification of effectiveness, etc.

• Determines root cause for NCRs, CAPAs, complaints, product failures, etc.

• Manages CAPA system and makes suggestions for corrective actions, corrections, preventive actions, and effectiveness. Documents and closes CAPAs.

• Maintains calibration schedule and calibration of equipment. Controls calibration and manages non-conforming equipment.

• Reports on metrics related to the Quality Management System

• Initiates, investigates complaints from the company's products. Documents initiation, complaints, corrective action, if required. Manages complaint files. Performs decontamination of products. Handles returns on products.

• Updates risk management files

• Assists with sterilization configuration, sterilization documents, sterilization review, sterilization release

• Performs OHR review of documentation including label verification prior to final release of documentation

• May perform or assist in design, product, process, sterilization validations, etc.

• Other duties as assigned.

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill and/or ability required for his position.

• Bachelors or Masters degree in Science, Engineering or related discipline

• Five (5) years of related medical device industry experience is preferred.

• Experience as Quality Engineer of start-up medical device companies.

• Experience with initiating, implementing, and maintaining a Quality Management System in accordance with ISO 13485, 21 CFR Part 820, and MDSAP.

• Experience with Notified Bodies, FDA, Competent Authorities, etc

• Experience with deciding on substantial changes required notification to regulatory authorities.

• Experience with eMDRs and Vigilance Reports

• Experience with NCR and CAPA closure

• Experience with internal and external audits.

TRAVEL REQUIREMENTS

Up to 5%

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