QUALITY ENGINEER/COMPLIANCE SPECIALIST

Snap Diagnostics

Job Description

Position: Quality Systems Specialist

Department: Quality Exempt (Y/N): N

Employee Name: Shift: Day

Supervisor: Location: Vernon Hills, IL

Summary:

This position requires a strong knowledge of ISO 13485 and 21 CFR 820

This is an in-office, hands on position, working with quality and service on complaints, nonconformances, CAPA’s, internal auditing and quality control ensuring regulatory alignment.

This position is responsible for ensuring products and manufacturing processes meet quality standards, safety regulations, and customer requirements in the quality systems. Task associated to conducting audits and analyzing defect data and providing support and oversight to our quality management system by maintaining documentation for regulatory requirements, working with engineering on documentation to support new and existing projects, and participating in the auditing process. Maintain knowledge of ISO 13485:2016 Quality Management System Regulations (QMSR) and related standards.

Employee is responsible for upholding and guiding company initiatives to ensure a quality management system is maintained according to policies, procedures and processes that support the standards and guidelines for regulatory agencies including but not limited to The Joint Commission, Food and Drug Administration, (FDA), International Organization Standards (ISO) and Federal health care guidelines and the Snap Quality Management System.

Essential Duties and Responsibilities include the following. Other duties may be assigned that are within the scope of this position.

• Data trending, analysis and reporting
• Collaborate with vendors to ensure raw materials and components meet specifications
• Document quality assurance activities with internal reporting and audits
• Interpret, build upon and comply with company’s quality/regulatory system standards
• Provide support for external audit with notified bodies
• Conduct root cause analysis for product and software
• Assist with quality control for production processes
• Work closely with service on service records, compaints and not conformances
• Support and conduct internal audits
• Conduct investigations on identified failures and nonconformities
• Comply with and maintain the complaint, nonconformity and corrective action process and procedures using records and tracking systems, including root-cause analysis
• Support the process for new standard development for production and design with improvements as needed and create testing protocols.
• Stay up to date with standards
• Other tasks to support company activities requiring quality oversight

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience

• Engineering degree preferred or equivalent experience.
• Must have at least 3 years of practical experience. Relevant experience and/or certifications will be considered.
• Experience in regulated environments for medical devices or similar industries.
• Hands-on experience in complaint handling, nonconformance processing, root cause analysis and required documentation.
• Strong knowledge of ISO 13485:2016, Quality Management System Standards (QMSR), 21 CFR 820, ISO 14971:2019, and GUDID Labeling requirements.

Language Skills

Ability to read, write and interpret documents in English such as safety rules, operating and maintenance instructions and procedure manuals.

Reasoning Ability

The individual in this role must be able to apply common sense understanding to carry out instructions furnished in written, oral or diagram form.

Other Skills and Abilities

Strong multi-tasking skills. Ability to complete assigned tasks in the allotted time. Attention to detail and good problem-solving skills.

Physical Demands

• Must be able to remain in a stationary position (standing or sitting) greater than 75% of the time.
• Constantly operates a computer and other office equipment.
• Position self to maintain files and move about inside the office to access file cabinets, office machinery, etc.
• The ability to observe details and communicate information and ideas so others will understand. Must be able to exchange, detect, perceive, identify, recognize, judge, observe, and inspect accurate information in these situations.
• Ability to lift a minimum of 40 pounds.

Travel Requirements: Work travel is seldom required.

Work Environment:

The work environment includes a general office environment with relatively low noise.

This position is onsite at our Vernon Hills office.