Quality Systems Analyst

Quality Systems Analyst (Medical Device Industry)Quality Systems Analyst (Medical Device Industry)

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Job Description

Position Job Title: Quality Systems Analyst (Medical Device Industry)

Scope: Outsourced (NetRoots Technologies LLC)

Type: Full Time

Job Family Group: Quality

Job Family: Quality Systems

Experience: 3 – 5 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:

oMonitor and track alignment to Quality Standards and any other quality system initiatives.

oEnsures quality systems are effectively deployed.

oPerforms periodic checks to verify appropriate application.

oUses statistical methods, quality tools and computer-generated reports to continuously improve process capability.

oMonitors and reports Quality Management System metrics.

oLeads and participates in quality system improvement initiatives.

oConducts internal audits to determine compliance with quality management system standards as well as regulatory and customer requirements.

oDetermines root causes of quality issues and develops corrective actions and recommendations. Suggests process changes when appropriate.

oEstablishes, maintains and implements communications to increase awareness and promote improvement of quality issues across the business.

oAssists department head in implementing new product development procedures and documentation.

oProvides audit back room support (for Notified Body, FDA, or customer audits) as required

oAssists with external audits, generating reports with corrective action plans and ensuring implementation of corrective actions in a timely fashion.

oManage CSS companies records management process including but not limited to:

oIdentify, compile, and prepare a records management tool or use existing Records Management Information System to track all CSS records internally and externally.

oManage and execute the process in accordance to internal, and regulatory requirements, standards and guidelines for Records management.

oIdentify the retention period per company policy for each document or record type.

oManage external contract facilities which hosts records

oImplement and manage an effective way of retrieving documents and records for business and compliance needs.

oProvide support for internal and external audits as a lead auditor and/or Front Room-Back Room Team Member

oCoordinate records and information management program activities, including annual assessments of each department

oCommunicate with Corporate Regulatory bodies and Facility counterparts to coordinate compliance activities

oProvide periodic reports, completes special assignments, assists supervisor as requested

oCoordinate and participate in special projects as assigned

oProvide support to assigned Quality Systems areas

oResponsible for communicating business related issues or opportunities to next management level

oResponsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

oFor 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

oResponsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

oPerforms other duties assigned as needed

SECTION 3: EXPERIENCE AND EDUCATION*

oBachelor's degree or equivalent experience or equivalent.

o2 - 5 years in Quality Systems

oExperience in FDA regulated industry

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

oKnowledge of 21 CFR Part 820, ISO 13485 and familiarity with ISO 14971.

oKnowledge of Microsoft Office or Proficient in Microsoft Office

oAbility to function independently as well as part of a team

oExcellent written and verbal communication skills

oAbility to manage multiple priorities in fast-paced environment

oGood planning, multi-tasking, and project management skills

oDemonstrated track record of completing projects on time and accomplishing goals

oAbility to manage multiple priorities in fast-paced environment

oASQ 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.

RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS

☐This Section is Not Applicable

oReports to Quality Systems Manager

oWorks with other department such as Engineering, Supplier Quality and Supply Chain to ensure that a variety of business transactions are completed

oParticipate in Management Review

oHost business meetings with other functions

SECTION 9: EXTERNAL INTERACTIONS ☐ This Section is Not Applicable

oOn 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.

Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionQuality Assurance
• IndustriesIT Services and IT Consulting

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