Quality Systems Specialist II

Job Title:

Quality Systems Specialist II

Department:
Quality

Reports to:
Director of Quality

Work Location:

In-Person

Pay Range:
$85,000-$100,000 based on experience

Position Type and Expected Hours of Work:
Full-Time, Monday-Friday, 40 hours/week

Job Summary:
The Quality Systems Specialist II is responsible for ownership and continuous improvement of multiple elements of Elucent Medical's quality management system, with primary ownership of the Corrective and Preventive Action (CAPA) and internal audit programs. The position provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of products and services conform to established internal and external standards and regulations. The position works cross functionally with process stakeholders to ensure quality system processes are documented appropriately, completed within the expected timeframes, and effective. The Quality Systems Specialist II leads the coordination and preparation of document packages for internal audits, FDA inspections and external audits, and supports the Quality Director and Regulatory Affairs with quality system content for regulatory submissions. The position operates with a high degree of independence, exercising judgment on investigation scope, root cause, risk, and the adequacy of corrective actions. Other duties may be assigned.

Supervisory Responsibilities:
Provides technical guidance and backup support to other Quality Systems staff as needed; no direct reports.

Job Responsibilities:

• Assures all Quality Systems documentation and Record keeping activities are carried out and completed in compliance with established procedures and work instructions.
• Serves as system owner for two or more quality system elements (e.g., Document control, Training, CAPA, audit, management review, etc.). In this role, they are responsible for the effectiveness of the system and management of all activities tied to the system including procedure ownership, training, issue resolution, metrics reporting, etc.
• Supports completion of DCRs, CAPA, and Corrections in a timely manner.
• Plans, schedules, and leads the internal audit program, including audit execution, reporting, and follow-up of findings to closure; maintains audit program records and auditor qualifications.
• Controls and maintains externally supplied documentation other than prints and specifications, as required.
• Coordination of collection and reporting of quality metrics and trends; identifies adverse trends and initiates appropriate action
• Authors, revises, and improves quality systems procedures; performs gap assessments against 21 CFR Part 820 (QMSR), ISO 13485:2016, and related standards and drives remediation
• Leads preparation for, and serves as a front-room or back-room representative during, FDA inspections and external audits, including coordinating document requests, drafting responses to observations, and managing associated corrective actions, in compliance with established procedures and work instructions
• Develops and delivers training on the quality system elements owned by the position and defines training requirements for associated procedure changes
• Compiles and analyzes quality system inputs for Management Review, presents data and recommendations, and tracks resulting actions to closure
• Drives continuous improvement of quality system processes and eQMS workflows; serves as subject matter expert on QMSR and ISO 13485 requirements
• Supports Regulatory Affairs with quality system documentation and evidence for regulatory submissions.
• Provides technical guidance, review, and backup support to Quality Systems staff responsible for all elements of the quality system
• Demonstrates safe work habits, maintains clean and safe work area
• Completes all other duties as assigned by supervisor

Qualifications

Education and Experience:

• Bachelor's degree required in engineering, life sciences, or a related technical field; an equivalent combination of education and directly relevant experience will be considered
• Minimum 5 years relevant medical device quality systems/ISO 13485 experience required, including demonstrated ownership of at least two quality system elements, one of which must be CAPA or internal audit.
• Demonstrated experience leading CAPA investigations using structured root cause analysis methods and verifying corrective action effectiveness.
• Demonstrated experience leading internal audits; ISO 13485 Lead Auditor certification or ASQ Certified Quality Auditor (CQA) preferred.
• Direct experience supporting FDA inspections or third-party quality system audits.
• Technical writing as well as excellent written and oral communications skills required.
• Excellent computer skills including MS Office, Adobe Acrobat, and electronic QMS (eQMS) platforms.
• Working expertise of medical device quality management systems including 21 CFR Part 820 (QMSR) and ISO 13485; familiarity with ISO 14971 risk management.

Required Skills/Abilities:

• Individual must have a hands-on approach.
• Strong organizational and time management skills.
• Recognized as a technical leader within the company and maintains positive attitude when working with peers, customers or suppliers.
• Comfortable working in a self-directed team environment and giving or asking for instructions.
• Ability to work independently with minimal supervision, exercising sound judgment on investigation scope, risk, and adequacy of corrective actions.
• Demonstrated ability to apply the medical device regulatory environment to day-to-day quality decisions.
• Works effectively on cross functional teams to establish appropriate processes pertaining to quality, and influences and facilitates teams without direct authority.
• Excellent written and oral communication skills.
• Ability to formulate responses to common inquiries from internal and external customers and regulatory agencies, including responses to audit and inspection observations.
• Ability to review, analyze, summarize and interpret data; draw conclusions and make appropriate recommendations and decisions.

Physical Requirements / Work Conditions:

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.
• Office, Manufacturing floor

Fulltime Employees are provided:
401(k)
401(k) matching (4%)
Dental insurance
Health insurance
Vision insurance
Paid Holidays
Paid Vacation Days
Paid Sick Days
Short Term Disability
Long Term Disability
Life Insurance
Pet Insurance
Employee Assistance Programs