The Senior Quality Assurance Specialist is responsible for executing various tasks for Quality Assurance and Manufacturing Operations processes within Urgo Medical North America (UMNA). The primary responsibility is supporting CAPA processing and complaint investigations to ensure compliance with the US FDA regulations and UMNA standard operating procedures. This role will independently engage in root cause analysis and technical investigations of complaints and out of specifications (OOS) events within UMNA and those related to contract manufacturing organizations (CMOs) and suppliers.  

This role is also responsible for assisting with QMS training, quality audits, regulatory inspections, product releases and incoming product verifications, product and material specification development, and other QMS activities as needed, in support of the UMNA QMS objectives. The Senior Quality Assurance Specialist will provide QMS support to the various functional organizations within UMNA. The role will perform additional duties as required to support Quality Assurance, Regulatory Affairs, and Research and Product Management.  

This is an onsite role in Fort Worth, Texas.

Duties and Responsibilities

• Ensure the thorough and accurate processing of CAPAs, including root cause analysis (RCA), solution development, and effectiveness verification for internal and external CAPAs.
• Assist CMOs with technical investigations and monitor for timely responses related to CAPAs and complaints.
• Collaborate with Customer Success in the handling of complaints, initiate reporting of Medical Device Reporting/Adverse Events (refer to 21 CFR 820.198 and 21 CFR 803), and oversee complaint investigation execution.
• Collaborate with Medical Affairs as needed to obtain guidance and expert subject matter on complaints related to adverse reactions, and for final resolution determination.
• Develop and distribute periodic CAPA and complaint status reporting.
• Ensure QMS documented information and records control processes meet GDP compliance.
• Support QMS processes such as document change requests, change control requests, nonconformities, and audit activities.
• Support the periodic review of QMS documents according to ISO requirements.
• Contribute toward the implementation and improvements of eQMS applications and tools.
• Assist with and support QMS training cross-functionally and within the team, as needed.
• Support and participate in internal and external audits, regulatory inspections, and supplier audits, as needed.   
• Other duties as assigned.

Competencies

• Steadfast, inquisitive propensity to analyze problems in-depth.
• Knowledgeable in systems and process development and mapping.
• Well-developed written and oral communication skills.
• Highly organized, attention to detail, self-directed, and self-motivated.
• Ability to work effectively at a fast pace with cross-functional departments and UMNA suppliers to finalize time-sensitive deliverables.
• Ability to successfully manage multiple priorities.
• Demonstrated ability to complete tasks independently, notifying immediate manager of decisions outside of established processes.
• Independent assessment and decision-making skills.
• Thorough knowledge of procedures, including cGMP (Current Good Manufacturing Practices) and GDP (Good Documentation Practices).

Requirements

• Bachelor’s degree is required.
• Experience with CAPA processing and complaint investigations.
• Competent in understanding of the regulatory landscape in the US, Canada, as well as MDR requirements.
• Knowledgeable in ISO 13485:2016 Standard requirements.
• Minimum 5 years of relevant document control management experience in a cGMP/FDA regulated environment.
• Experience in Project Management or Document Management preferred.
• Proficient in Microsoft Suite and other organizationally leveraged applications (e.g., Word, Adobe, Visio Excel, and SharePoint) and with QA Systems (e.g., Document Management System, Quality Management System).

Work Environment

• Indoors, in an office environment, with temperature control.
• No adverse environmental conditions expected.
• Limited travel requirements – 0-10%.

Physical Demands

• Sedentary work. Exerting up to 15 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. Repetitive motion. Substantial movements (motions) of the wrists, hands, and/or fingers. The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; the ability to operate standard office equipment and keyboards.

The above description is intended to describe the general content, identify the essential functions of, and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.