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.
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.
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.
for development and implementation of quality systems based on business,
regulatory and customer requirements.
Job Duties and Responsibilities:
Ensures quality systems are effectively deployed. Performs periodic checks to verify
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
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
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
required periodic re-training and assure that required periodic re-training
takes place for direct reports in areas such as environmental health &
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
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
Excellent written and verbal communication skills are required.
Ability to manage multiple priorities in fast-paced environment is
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
Sterilmed, Inc. (6215)Job Function
Quality (Eng)Requisition ID