Sr Specialist, Quality Assurance

Ansell

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profile Job Location:

Querétaro - Mexico

profile Monthly Salary: Not Disclosed
Posted on: 20 hours ago
Vacancies: 1 Vacancy

Job Summary

Why Ansell

At Ansell we stay two steps ahead of workplace risk to deliver innovative safety solutions that enhance peoples quality of life. As a global leader in protection solutions we design and develop a wide range of products including gloves clothing and other protective gear to keep workers safe and productive across industrial medical and consumer applications.

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 onsite visits product qualifications testing/trials CoA/CoC review product release and changecontrol coordination. The role supports complaint investigations through supplier documentation review defect evaluation and contributions to rootcause 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 empoweredacross 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 programs

Paid time off (vacation sick and personal days) according to federal job law.

Continuing Education Reimbursement

Regional Belonging & Inclusion Networks

Green 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: Bachelors in Chemistry Engineering or related field preferred; High School diploma with significant QA experience accepted.
  • Experience: 58 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.

Join us to lead the world to a safer future apply today!

Equal Opportunity Employer:

Ansell is committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee based on race color religion creed national origin or ancestry sex age physical or mental disability veteran or military status genetic information marital status parental status or any other legally recognized protected basis under federal state or local law. The information collected by this application is solely to determine suitability for employment verify identity and maintain employment statistics on applicants. Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act and certain state or local laws. A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing undue hardship on Ansell. Please inform the companys personnel representative if you need assistance completing this application or to otherwise participate in the application process.

Ansell is an EO Employer M/F/Vets/Disabled and other protected categories.

Our Commitment to Belonging and Inclusion:

Ansells 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. its 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! Its what drives Ansell as an organization towards a workforce that reflects the communities in which we operate its what drives us to serve our customers and stakeholders with pride and its what differentiates Ansell.

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Required Experience:

Senior IC

Why AnsellAt Ansell we stay two steps ahead of workplace risk to deliver innovative safety solutions that enhance peoples quality of life. As a global leader in protection solutions we design and develop a wide range of products including gloves clothing and other protective gear to keep workers saf...
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About Company

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We lead the world to a safer future by providing you with a wide portfolio of personal protective equipment no matter your industry.

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