Quality Systems Analyst

Job Description

Position Job Title: Quality Systems Analyst

Scope: Outsourced (NetRoots Technologies LLC)
Type: Full Time

Job Family Group: Quality
Job Family: Quality Systems

Experience: 3 – 6 Years

SECTION 1: JOB SUMMARY*

Responsible for development and implementation of quality systems based on business, regulatory and customer requirements. Also provides training and consultation to various parts of the business and resolves procedural breakdowns.

SECTION 2: DUTIES & RESPONSIBILITIES*
In accordance with all applicable federal, state and local laws/regulations and Corporate, procedures and guidelines, this position:

Monitor and track alignment to Quality Standards and any other quality system initiatives.
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.
Monitors and reports Quality Management System metrics.
Leads and participates in quality system improvement initiatives.
Conducts internal audits to determine compliance with quality management system standards as well as regulatory and customer requirements.
Determines root causes of quality issues and develops corrective actions and recommendations. Suggests process changes when appropriate.
Establishes, maintains and implements communications to increase awareness and promote improvement of quality issues across the business.
Assists department head in implementing new product development procedures and documentation.
Provides audit back room support (for Notified Body, FDA, or customer audits) as required
Assists with external audits, generating reports with corrective action plans and ensuring implementation of corrective actions in a timely fashion.
Manage CSS companies records management process including but not limited to:
Identify, compile, and prepare a records management tool or use existing Records Management Information System to track all CSS records internally and externally.
Manage and execute the process in accordance to internal, and regulatory requirements, standards and guidelines for Records management.
Identify the retention period per company policy for each document or record type.
Manage external contract facilities which hosts records
Implement and manage an effective way of retrieving documents and records for business and compliance needs.

Provide support for internal and external audits as a lead auditor and/or Front Room-Back Room Team Member
Coordinate records and information management program activities, including annual assessments of each department
Communicate with Corporate Regulatory bodies and Facility counterparts to coordinate compliance activities
Provide periodic reports, completes special assignments, assists supervisor as requested
Coordinate and participate in special projects as assigned
Provide support to assigned Quality Systems areas
Responsible for communicating business related issues or opportunities to next management level
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Performs other duties assigned as needed

SECTION 3: EXPERIENCE AND EDUCATION*

Bachelor's degree or equivalent experience or equivalent.
2 - 5 years in Quality Systems
Experience in FDA regulated industry

SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*

Knowledge of 21 CFR Part 820, ISO 13485 and familiarity with ISO 14971.
Knowledge of Microsoft Office or Proficient in Microsoft Office
Ability to function independently as well as part of a team
Excellent written and verbal communication skills
Ability to manage multiple priorities in fast-paced environment
Good planning, multi-tasking, and project management skills
Demonstrated track record of completing projects on time and accomplishing goals
Ability to manage multiple priorities in fast-paced environment
ASQ Certification and/or Six Sigma training desired; Project Management/Excellence; Quality Systems and ISO regulations, software application knowledge preferred: EZDOC, EtQ, Compliance Wire, Siebel, Microsoft Professional Office Suite (MS Word, MS Excel, MS Outlook, MS Access)

SECTION 5: TRAINING PLAN REVIEWED AND/OR UPDATED* (Check all that apply)
Note: If this is a new or updated JD, Training shall be notified per selections below.

☒ Update to an Existing Job Description
Training plan/curriculum reviewed with Training Representative and updated.
☒ Training plan/curriculum reviewed, and no update is required.

New Job Description

Training plan/curriculum implemented together with the Training Representative
Training plan/curriculum reviewed, and no update is required.

SECTION 6: ADDITIONAL POSITION REQUIREMENTS

☒ This Section is Not Applicable

SECTION 7: RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS

This Section is Not Applicable
Reports to Quality Systems Manager
Works with other department such as Engineering, Supplier Quality and Supply Chain to ensure that a variety of business transactions are completed
Participate in Management Review
Host business meetings with other functions

SECTION 9: EXTERNAL INTERACTIONS

☐ This Section is Not Applicable
On occasion may support interaction with government agencies or Competent Authorities to support audit activities or information follow-up.

COMPANY DISCLAIMER:

Company management reserves the right to add, delete or otherwise alter assigned duties at any time. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The minimum qualifications listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.