Sr Specialist, Quality Assurance

**Sr Specialist, Quality Assurance** **-** **(** **)****Description****Why Ansell?**Discover more about our company, our people, and our values by visiting us at Ansell.**Ansell is looking for a Quality Assurance Sr. Specialist to join our team in Queretaro**Responsible for regional supplier management to ensure products meet customer expectations and regulatory/ISO requirements. Key duties include supplier audits, on‑site visits, product qualifications, testing/trials, CoA/CoC review, product release, and change‑control coordination. The role supports complaint investigations through supplier documentation review, defect evaluation, and contributions to root‑cause analysis and CAPA activities. Additional responsibilities include managing product specifications, resolving nonconformances and deviations/rework, and partnering with suppliers on corrective actions. The position ensures daily audit readiness with complete, accurate records and supports preparation for external and certification audits. It also includes product inspections, evaluations, and trending analysis, with other tasks assigned by QA leadership.**What benefits and opportunities does Ansell offer?**Competitive compensation plan, including a performance based annual incentive.Flexible and hybrid work model.A culture of belonging and inclusion, collaboration thrives, and everyone feels seen, heard, and empowered—across our global community.Ansell University, LinkedIn Learning and Mentorship programs to develop professional and interpersonal skills.Opportunities to advance and grow within the company through LinkedIn Learning and Mentorships.Health Benefits: medical, dental, vision, short term and long- term disability and wellness programsPaid time off (vacation, sick and personal days) according to federal job law.Continuing Education ReimbursementRegional Belonging & Inclusion NetworksGreen office concept and a global mission of sustainability**What your role will be?**Product Inspections & Audits**- Conduct onsite and virtual inspections, surveillance, and quality audits of manufacturing partners to ensure compliance with specifications, regulations, and ISO standards.- Review test results, identify discrepancies, verify corrective actions, and support complaint investigations.- Prepare inspection reports, trending charts, and maintain quality dashboards for analysis and audit readiness.**Supplier Management & Audits**- Perform supplier quality system audits per ISO 9001, ISO 13485, FDA 21 CFR 820.- Collaborate with suppliers to resolve quality issues (nonconformances, deviations, CAPA).- Monitor supplier performance and maintain qualification and documentation.**Sample Evaluation & Product Qualification**- Support product evaluations, qualifications, and first article inspections.- Conduct testing, comparisons, and provide analysis with recommendations.- Perform multi-source evaluations and trending for root-cause analysis.**Change Control**- Manage supplier change requests and maintain Change Control records.- Ensure cross-functional review, approval, and post-implementation effectiveness.**Documentation & Compliance**- Review CoAs/CoCs for compliance; escalate OOS/OOC results.- Maintain SOPs aligned with regulatory and ISO requirements.- Prepare reports, maintain quality documentation, and support audits.- Present data at Management Reviews and ensure eQMS records are audit-ready.**Other Responsibilities**- Support complaint investigations, CAPA activities, and QA projects as assigned.**What will you bring to Ansell?**- **Education**: Bachelor’s in Chemistry, Engineering, or related field preferred; High School diploma with significant QA experience accepted.- **Experience**: 5-8 years in Quality (medical devices preferred), ISO 9001/13485, FDA 21 CFR 820, supplier quality, complaint investigations, root-cause analysis.- **Skills**: Fluent English (Spanish a plus), strong technical writing, MS Excel/Word/PowerPoint, eQMS (FourthShift, and AutoCAD) and ERP systems, analytical and problem-solving skills.- **Competencies**: Independent work, organization, time management, communication, adaptability, teamwork.- **Physical**: Ability to sit, bend, walk, and lift up to 15 lbs.- **Travel**: Up to 30% to regional suppliers.**Equal Opportunity Employer**:Ansell is an EO Employer - M/F/Vets/Disabled and other protected categories.**Our Commitment to Belonging and Inclusion**:Ansell’s vision is about creating safe spaces where all perspectives are valued alongside individual contributions. When we say that everyone deserves to belong, feel included and empowered at work., it's not just words. We want applicants to know that we endeavor to create an inclusive environment that will consider all, regardless of age, gender, background, disability, veteran status, or experience alone It’s what drives Ansell as an organization towards a workforce that reflects the comm