Sr Specialist, Quality Assurance

Ansell; Santiago de Querétaro; Presencial; MXN 200,000 - 400,000; Jornada completa

Descripción de la vacante

A global protection solutions company in Querétaro is seeking a Quality Assurance Sr. Specialist. You will be responsible for managing regional supplier performance, conducting audits, and ensuring compliance with quality standards. The ideal candidate has 5-8 years of experience in quality within the medical device sector and familiarity with ISO and FDA regulations. This position offers competitive compensation, flexible work options, and opportunities for professional growth within a diverse environment.

Servicios

Competitive compensation plan

Flexible and hybrid work model

Health benefits including medical, dental, and vision

Continuing Education Reimbursement

Formación

• 5–8 years in Quality (medical devices preferred), ISO 9001/13485, FDA 21 CFR 820.
• Experience in supplier quality and complaint investigations.
• Ability to travel up to 30% to regional suppliers.

Responsabilidades

• Conduct onsite and virtual inspections, surveillance, and quality audits.
• Perform supplier quality system audits per ISO 9001, ISO 13485, FDA 21 CFR 820.
• Manage supplier change requests and maintain Change Control records.

Conocimientos

Fluent English

Strong technical writing

MS Excel/Word/PowerPoint

Analytical skills

Problem-solving skills

Educación

Bachelor’s in Chemistry, Engineering, or related field

High School diploma with significant QA experience

Herramientas

eQMS (FourthShift)

AutoCAD

ERP systems

Descripción del empleo

Why Ansell?

At Ansell, we stay two steps ahead of workplace risk to deliver innovative safety solutions that enhance people's 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, 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 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; elevate 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
  • 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.

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 company’s personnel representative if you need assistance completing this application or 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:

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 communities in which we operate, it’s what drives us to serve our customers and stakeholders with pride, and it’s what differentiates Ansell.