Summary
The Quality Assurance Engineer shall complete Quality Assurance projects and recurring responsibilities in furtherance of the creation, implementation, and maintenance of the IMPAC Quality System, as directed by the Quality Assurance Manager. The primary focus of the Quality Assurance Engineer shall be to perform the required duties to support the day to day operation of the IMPAC Quality System.

Essential Duties & Responsibilities
The Quality Assurance Engineer must be quick to evaluate circumstances and seek necessary information or resources to secure a full understanding of the situation and/or requirements to be resolved. The employee must be very reactionary and adaptable to abrupt changes, arising issues, extreme time pressures, and other exigent circumstances, while being creative, thorough, and persuasive enough to effectively maintain the state of control required for Quality System effectiveness. This must be done without violating any policy or intent of the IMPAC Quality System and the Constitution of IMPAC Medical Systems, Inc.

Responsibilities include drafting procedures and documents, assisting employees with the understanding and performance of their Quality System responsibilities, analyzing the need for process changes, internal auditing, employee training, document revision, document control, performing and documenting software and component validation, and evaluation and interpretation of regulatory and standards schemes applicable to IMPAC. Other duties shall be defined, as necessary, by the Quality Assuance Manager during the course of employment. The Quality Assurance Engineer must remain willing and able to support the immediate need to maintain the "State of Control," as identified by the Quality Assurance Manager. Other duties may be assigned.

Qualifications

• Organizational Management System Experience: Quality culture building, Project management, Team management, Interfunctional coordination, Employee training, Statistical analysis, Management reporting.


• Quality System Experience: Technical writing, Procedure writing, Quality system structuring, Document control, naming, and version control , Corrective/preventive action, Internal quality auditing, Verification and validation, Change control and planning.


• Regulatory Experience: Medical device regulation, Application of external standards, Auditing to an external standard, External regulatory audits, Laws and regulations, Risk management.


• Basic Administration Experience: Basic office software applications, Online research, Critical reading, Filing and labeling, Typing / data entry, Proofreading, grammar, and spelling, Report and record generation, Multi project queueing and multitasking.


• Excellent written & verbal communication skills

Education/Experience
Bachelor’s degree in a related field (Business Management, Quality Assurance, Law and Regulation, Technical Sciences, Engineering) and a minimum of three years related quality system /organizational or operational management /regulatory compliance /quality auditing experience. Medical device and software design control experience preferred. Certified Quality Auditor preferred.