Quality Assurance Specialist

Exalta Group•Village of Somers, WI

8d•$65,000 - $75,000•Hybrid

About The Position

This position is responsible for the implementation of inspecting activities, detection of problem areas, and delivering quality inspection outcomes. In addition, they are in charge of planning and performing corrective actions if defects are found. This position requires knowledge of FDA regulations for Medical Devices, ISO standards, and participation in regulatory inspections and customer audits. The role involves utilizing organizational skills to engage in team dynamics, company performance, interpersonal relationships, improvement systems, and professional ethics.

Requirements

Minimum of 5 years of experience with medical device quality management system (ISO 13485 and FDA 21 CFR Part 820).
2+ years of experience in quality auditing for medical device or pharmaceutical companies.
Knowledge of Medical Device Risk Management Regulation ISO 14971.
Ability to communicate effectively in multi-discipline, cross-cultural environments and at various levels of the organization.
Advanced knowledge and experience of the CAPA and complaint process in a medical device manufacturing facility.
Experience with content management/quality systems, archiving, and control techniques.
Strong problem-solving, critical thinking, and analytical skills.
Ability to drive decisions and make independent decisions with minimal oversight.
Ability to work in a team environment, as well as autonomously.
Capable of handling stressful situations.
Excellent verbal and written communication skills.
Detail-oriented with strong organizational skills.
Willingness to accept new assignments and projects pertaining to different areas or products.
Ability to read and comprehend complex instructions.
Ability to maintain a sense of urgency and prioritize workload.
Ability to effectively manage projects.
Computer literate in various software applications (i.e., Microsoft Office).

Nice To Haves

Bachelor’s Degree (Life Sciences Preferred) or equivalent experience.

Responsibilities

Auditing plant processes to ensure adherence to internal and external regulations and standards (e.g., FDA 21 CFR 820, ISO 13485, etc.).
Ensuring auditing and manufacturing documentation is kept up to date.
Reviewing Intech documents to ensure company processes comply with Quality System (QS) Regulation/Medical Device Good Manufacturing Practices.
Training new and existing employees on Intech procedures, work instructions, policies, protocols, and documentation.
Supporting the document change control (DCN) process, customer specification notification (CSN) process, and ensuring impacted employees are trained per requirements on the training matrix.
Supporting NCR and CAPA activities through product non-conformance control, including capturing data and investigations associated with product deviations, product non-conformances, CAPAs, scrap, and rework. Analyzing data for Quality Improvement and reporting.
Being proficient in the complaint handling process through review of data, trend evaluations, and investigations associated with product and customer complaints. Analyzing data for Quality Improvement and reporting.
Actively tracking CAPAs and Complaints as needed and ensuring tasks are completed on time. Assisting the team in developing solutions to problems and offering possible improvements to processes and systems.
Supporting the management of the day-to-day operation and responsibilities of document control to ensure all users have the latest revision of appropriate Bradshaw Medical documentation.
Managing a schedule for periodic review of QMS documentation, review, and effective implementation dates to ensure documentation remains current with regulations, standards, and business needs.
Ensuring personnel within areas of responsibility are competent to perform new tasks and continuity of same; evaluating training needs regularly, but at least annually.
Maintaining the internal training program and training matrix(s) by ensuring all employees are trained to the current revisions of QMS documentation per individual job descriptions.
Supporting Risk Management activities including data preparation for annual product risk file review, management and preparation of event-based reviews, and review and coordination of quality activities related to risk matrices.
Scheduling and conducting internal audits and leading and managing supplier audits, monthly supplier performance evaluations, and supplier corrective actions.
Assisting in preparations for internal and external audits. Participating in audits as needed. Supporting external regulatory audits as needed.
Assisting with supplier relationships and acting as the key escalation point for Intech QMS.
Assisting in preparing, conducting, evaluating, and facilitating quality-related training programs for employees based on training needs and certification requirements.
Providing support to Quality Management personnel and performing other duties as assigned.
Collaborating with other departments to meet customer requests.
Supporting accuracy metrics through identification and documentation of case handling errors.