Quality Assurance Specialists

PercuVision LLC

Bachelor's degree in a technical discipline or equivalent combination of education and experience in medical device quality systems and/or biomedical engineering.

• Minimum of 3 to 4 years experience with the specified responsibilities (job duties) in a regulated medical device environment.
• Experience with Microsoft Office Suite
• Experience with electronic record-keeping a plus.
• Demonstrated high attention to detail.
• Demonstrated effective interpersonal skills.
• Demonstrated ability to independently execute actions.
• Effective oral and written communication skills and ability to communicate effectively using English.

Primarily responsible to implement and monitor compliance for in-house product design and vendor management. Works closely with design and manufacturing processes. This position does not have any direct reports.

Position: Quality Assurance Specialists

Reports to: Sr. QA/RA Leadership

Status: Exempt

Job Duties:

• Maintain and manage QA/RA records, including DHF (Design History File),DMR (Device Master Record), and DHR (Design History Record).

• Implement supplier quality processes, product inspection/acceptance activities, nonconformance evaluation and investigation, complaints and related activities.

• Conduct supplier site inspections and audits, supplier qualification activities, and manage supplier QA activities.

• Collaborate with QA/RA consultants to develop and improve documentation processes for in-house product design control and development, and production and process control activities, including supplier quality management, document change processes, process verification and validation, CAPA, risk management, and employee training programs.

• In collaboration with other PercuVision departments, maintain and develop corporate document control.

Interested candidates should forward their resume (as a .docx or .pft file) with salary history to jobs@percuvision.com