Senior Quality Assurance Specialist

Senior Quality Assurance Specialist

Apply for the Senior Quality Assurance Specialist role at Urgo Medical North America
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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 US FDA regulations and UMNA standard operating procedures. The role independently engages in root cause analysis, technical investigations of complaints and out‑of‑specification events, and assists with QMS training, quality audits, regulatory inspections, product releases, incoming product verifications, product and material specification development, and other QMS activities as needed.

• Ensure the thorough and accurate processing of CAPAs, including root cause analysis, 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 handling complaints, initiate reporting of Medical Device Reporting/Adverse Events, and oversee complaint investigation execution.
• Collaborate with Medical Affairs to obtain guidance and expert judgment on complaints related to adverse reactions 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.

• 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 and GDP.

• Bachelor’s degree is required.
• Experience with CAPA processing and complaint investigations.
Competent understanding of the regulatory landscape in the US, Canada, and 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 (Word, Adobe, Visio, Excel, SharePoint) and QA systems.

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

• Sedentary work. Exerting Fall 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 of the wrists, hands, and/or fingers; close visual acuity for data analysis, transcribing, and computer use.

Mid‑Senior level

Full‑time

Quality Assurance

Medical Equipment Manufacturing