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QUALITY SYSTEMS ANALYST
Requisition ID: 8898170203
The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Quality Systems Analyst to be based out of Plymouth, MN.
The CSS Group consists of six diverse businesses including Acclarent, Advanced Sterilization Products (ASP), Biosense Webster (BWI), Codman Neuro, Mentor, and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Neurovascular and Neurosurgery, Surgical and Non-SurgicalAesthetics, and Reprocessing.
Sterilmed is an FDA-registered medical device manufacturer that provides solutions for hospitals faced with the challenge of improving environmental sustainability and reducing costs without compromising patient care. We are proud to be a part of keeping healthcare accessible and affordable for all by offering services that support device recycling and reprocessed products that deliver cost savings for our customers.
Responsible for development and implementation of quality systems based on business, regulatory and customer requirements.
Essential Job Duties and Responsibilities:
- · Ensures quality systems are effectively deployed. Performs periodic checks to verify appropriate application.
- · Uses statistical methods, quality tools and computer generated reports to continuously improve process capability. Leads and participates in quality system improvement & initiatives in a cross functional environment.
- · Determines root causes of quality issues and develops corrective actions and recommendations and documents results in the appropriate quality system.
- · Establishes, maintains and implements communications to increase awareness and promote improvement of quality issues across the business
- · Provides audit back room support (for Notified Body, FDA, or customer audits) as required
- · Monitors and reports Quality Management System metrics.
- · Monitor and track alignment to J&J Quality Standards and any other quality system initiatives.
- · Creates and revises documentation in change control process to improve quality system processes as needed.
- · Committed to building a positive culture
- · Other responsibilities may be assigned & not all responsibilities listed may be assigned
- · POLICIES: Know and follow Sterilmed and Johnson & Johnson policies and procedures related to work activities performed in area of responsibility
- · TRAINING: Complete training in area of responsibility within allowed time-period. Training is required for changes in existing policies & procedures, for new assignments and for implementation of new policies & procedures. Complete required periodic re-training in areas such as environmental health & safety
- · SAFETY: Follow all company safety policies & other safety precautions within work area. Promote safety to all associates that enter the work area
- · procedures. Complete required periodic re-training and assure that required periodic re-training takes place for direct reports in areas such as environmental health & safety
- · SAFETY: Set standards for safe behavior. Recognize and reward safe behavior in others. Ensure that direct reports employ safe practices. Enforce safety policies & procedures. Evaluate staff member’s safety performance & insure that safety is a part of each direct report’s performance appraisal.
- Required and Preferred Experience and Skills:
- · Education, Skills, & Experience Needed to Perform Position Function:
- · Bachelor degree or equivalent experience is required.
- · 1+ years in Quality Systems is required.
- · Experience in FDA regulated industry is required.
- · Knowledge of 21 CFR Part 820, ISO 13485 and familiarity with ISO 14971 is required.
- · Prior experience in the medical device industry is preferred
- · Knowledge of Microsoft Office is required.
- · Ability to function independently as well as part of a team is required.
- · Excellent written and verbal communication skills are required.
- · Ability to manage multiple priorities in fast-paced environment is required.
- · ASQ Certification and/or Six Sigma training desired;
- · Project Management/Excellence; Quality Systems and ISO regulations
- · Familiarity with any of the following is preferred: EZDOC, EtQ, ComplianceWire, Siebel, Microsoft Professional Office Suite (MS Word, MS Excel, MS Outlook, MS Access).
- · This position is located in Plymouth, MN and may require some travel.
Sterilmed, Inc. (6215)