The Quality Assurance Specialist will collaborate with various stakeholders to develop, implement, and maintain the Quality Management System and its platform.
The QA Specialist will ensure documentation has been properly developed, execute risk assessments, corrective actions/preventive actions, support audits.
Essential Functions of the Areas of Responsibility
Evaluate adequacy of technical documentation per cGMP, ISO, FDA, and AATB.
Initiate, and support the execution and completion of investigations associated with material/product specifications and deviations.
Evaluate material/ product non-conformances to identify and assess root cause.
Interface with impacted departments to identify and evaluate risk associated with product impact.
Participate in meetings/projects as required (non-conformances, problem solving, team meetings).
Participate in process improvement teams and/or completes relative documentation when required.
Support quality manager in suggesting or communicating ideas for continuous improvement to maximize product quality, efficiency, and minimize costs.
Support compliance with established practices, polices, established to meet compliance with all applicable laws and regulations.
Support the management of risk assessments that pertain to or impact material and/or regulatory requirements.
General understanding of global medical device and tissue product regulations with experience with ISO 13485 and/or 21 CFR Parts 820
Minimum of 2 - 4 years’ experience with technical documentation for quality activities, such as corrective actions quality audits, and validation of manufacturing processes, or product development in an FDA regulated medical device and tissue environment.
Strong organizational and planning skills.
Be self-motivated, attentive to details and able to prioritize and meet deadlines.
Ability to communicate effectively, verbally and in writing, and demonstrate good interpersonal skills interdepartmentally and with stakeholders.