Senior Quality Assurance Specialist

POSITION SUMMARY:

The Senior Quality Specialist is responsible for conducting quality-related activities to deliver consistent high-quality documents, services, products, and processes. The Specialist will maintain Quality Management Systems (QMS) for the activities within their scope, as well as for effective and lean QMS operating processes, adhering to FDA QMSR and IS 13486 regulations.

ESSENTIAL FUNCTIONS:

To perform this job successfully, an individual must be able to perform each of the following essential functions satisfactorily.

• Lead change order and change management efforts (document controls) for the company, including manufacturing transfer of documents.
• Experience with writing standard operating procedures (SOP)
• Conduct internal ISO audits and inspections to ensure compliance with quality and regulatory standards. Compile evidence and generate report of findings to share with Lead Auditor.
• Perform acceptance testing (final QC) on all completed refurbished systems (SPECT / SPECTCT / PET / PETCT)
• Collaborate with cross-functional teams to integrate quality into all phases of the warehouse operations. Participate in lean improvement projects for problem solving and process optimization.
• Maintain comprehensive records of inspections, and tests to contribute to the Device Medical Files.
• Facilitate work installation updates with subject matter experts to ensure documentation describes processes while being compliant with all related requirements.
• Update records and maintain all necessary documentation and certificates.
• Responsible for following management of change as process and procedures are updated as per QMS requirements.
• Perform regular process audits in Manufacturing areas and functional areas, including technical work instructions, processes, procedures, competence and ensure compliance.
• Other duties as assigned.

Minimum Qualifications:

• Associate Degree or relevant military experience
• 5+ years of experience in Quality Assurance or Control with ISO 13485 and FDA QMSR knowledge
• Proficiency with Microsoft Office Suite

Preferred Qualifications:

• Bachelor's Degree
• Experience in document control or change analysis

Physical Demands:

• Must be able to lift up to 25 lbs.
• 10% standing or walking, 90% sitting

Working Conditions:

• Work is performed in a semi-quiet office setting and noisy warehouse setting.
• Travel may be required

Occupational Exposure:

Work involves exposure to potentially dangerous and hazardous materials. Work involves moderate exposure to unusual elements such as extreme temperatures, dirt, dust, fumes, odors, loud noises, and confined spaces.

Occupational Accommodations Statement:

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. They are representative to those knowledge, skills, and abilities that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of the role.

An Equal Opportunity Employer

We do not discriminate based on race, color, religion, national origin, sex, age, disability, genetic information, or any other status protected by law or regulation. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related