Quality Assurance Specialist

POSITION SUMMARY:

The Quality Assurance Specialist is responsible for activities that support company quality objectives related to the production of advanced imaging systems. The QA Specialist supports the Quality System in ensuring compliance with ISO 13485 standards, 21 CFR 820 regulations and Canadian standards with a high degree of mechanical aptitude. Primary responsibilities include in-process and final product inspection, preparation of inspection reports, Device History Record (DHR) review and approval, support of Nonconforming Material Report (NCMR) disposition and Material Review Board (MRB) activities, and participation in internal and supplier audits.

ESSENTIAL FUNCTIONS:

To perform this job successfully an individual must be able to perform each essential function satisfactorily.

1. Comply with established company policies and procedures, objectives, quality assurance program, safety, and environmental standards.
2. Inspect, diagnose, and document product and process quality issues to support repair and corrective actions.
3. Work closely with manufacturing, process, and quality teams to establish processes and procedures that will ensure consistently high quality.
4. Collaborate with engineering teams to support investigation, containment, and execution for strategic quality issues.
5. Adapt daily work activities to meet changing production schedules and quality priorities.
6. Assist with maintaining quality performance metrics and identifying root causes of quality issues.
7. Assist with Internal Audits and Supplier Audits according to regulations (FDA, ISO, Canada).
8. Audit manufacturing lines against released manufacturing processes and procedures.
9. Assist in the identification and resolution of manufacturing quality issues, contain parts or products as needed, sort parts for quality requirements.
10. Provide final inspection support and release of completed camera systems for shipment.
11. Participate in continuous improvement activities, with manufacturing and external suppliers.
12. Analyze and disposition component and product defects as a member of the Material Review Board.
13. Conduct receiving and inspection activities to ensure compliance to released design specs and drawings.
14. Provide support and/or maintenance of equipment calibration program.
15. Prepare accurate inspection reports, quality documentation, and other written communications.
16. Prioritize workload and adjust work assignments based on changing production and quality priorities.
17. Perform other duties as may be assigned.

Minimum Qualifications:

• Associates Degree or Equivalent Years of or Military Experience
• Three or more years of experience directly related to Quality Assurance in a production environment.
• Basic understanding of Quality Management Systems
• Ability to use Microsoft Operating Systems and QMS Programs

Preferred Qualifications:

• Bachelor's Degree in Engineering, Math, Science, or related discipline
• Experience in medical device manufacturing environment preferred.
• Experience with electronics diagnostics.
• Familiarity with medical device manufacturing, including the ability to read wiring diagrams and schematics.

Physical Demands:

• 15% Walking or Standing; 85% Sitting
• Pushing, pulling, lifting up to 40 pounds.
• Ability to see small items at a close distance, including judging spatial relationships to determine visual alignment and distinguishing colors.

Working Conditions:

• Work is performed in a semi-quiet office or warehouse setting. The warehouse may be noisy at times.

Occupational Exposure:

There is limited radiation exposure during nuclear medicine procedures when proper protocol is followed. Performance of clinical job duties has a reasonably anticipated risk factor of occupational exposure to blood-borne pathogens or other infectious materials. Employees are required to use protective equipment and follow all company and client best practices to minimize exposure.

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