Quality Engineer II

Coopervision; Monteiro Lobato; Presencial; BRL 80.000 - 120.000; Tempo integral

Resumo da oferta

A leading healthcare company is seeking a Quality Engineering professional to lead manufacturing quality initiatives. The candidate should possess expertise in ISO 13485 and have hands-on experience with CAPA and process validation. Responsibilities include overseeing quality inspections, providing mentorship, and collaborating with cross-functional teams to ensure product compliance. Strong organizational and communication skills are essential. This full-time position is located in Brazil with a day shift schedule.

Qualificações

• In-depth knowledge of ISO 13485, ISO 13408, EU MDR, MDSAP, and other global standards.
• Ability to work in a matrixed organization and collaborate with multidisciplinary teams.
• Hands-on experience with process validation, CAPA, and nonconformance management.

Responsabilidades

• Lead and support quality engineering activities for manufacturing processes.
• Conduct root cause investigations and manage nonconformances.
• Provide mentorship to junior quality engineers and technical guidance.

Conhecimentos

ISO 13485 knowledge

Process validation

CAPA management

Project management skills

Data analysis

Effective communication

Interpersonal skills

Microsoft Excel proficiency

Problem-solving skills

Descrição da oferta de emprego

CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more atwww.coopersurgical.com.

Responsibilities

• Lead and support quality engineering activities for manufacturing processes, including process validation, equipment qualification (IQ/OQ/PQ), and change management.
• Lead root cause investigations and corrective and preventive action (CAPA) using structured problem-solving methodologies.
• Manage and support the investigation, documentation, and disposition of nonconformances and deviations in accordance with quality system requirements.
• Maintain a working knowledge of aseptic processing concepts and implement requirements defined in a contamination control strategy.
• Partner with site leadership to support internal and external audits and inspections, and when necessary, represent Quality Assurance as a subject matter expert.
• Analyze quality metrics and trends; drive continuous improvement initiatives using Lean, Six Sigma, or similar methodologies.

Provide mentorship and technical guidance to junior quality engineers and quality inspectors.

• Collaborate cross-functionally with Manufacturing, R&D, Supply Chain, Regulatory Affairs, and other groups to ensure product quality and compliance throughout the product lifecycle.
• Where necessary, support supplier quality activities, including supplier qualification, performance monitoring, and issue resolution.
• Serve as quality representative on cross-functional teams for new product introduction (NPI), design transfer, and manufacturing scale-up.
• Crosstrain with multiple value streams as required by quality management.
• Perform other duties as assigned.

Qualifications

• In-depth knowledge of ISO 13485, ISO 13408, EU MDR, MDSAP, and other global standards.
• Ability to work in a matrixed organization, developing strong relationships with all levels of staff and management, partnering across multidisciplinary teams (internal/external).
• Hands-on experience with process validation, CAPA, nonconformance management, and change control.
• Strong time management skills to drive multiple projects to completion on time.
• Strong organizational, interpersonal, verbal, and written communication skills (clear, concise, effective with a variety of stakeholders).
• Strong data analysis, negotiation, and problem-solving skills.
• Must be proficient in the use of Microsoft Excel, Microsoft Word, Outlook, and PowerPoint.
• Experience in participating in regulatory audits/inspections is required.
• Proficient in reading, writing, and communicating in the English language.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace. If you are interested in applying and require special assistance or accommodations due to a disability, please contact us at [e-mail]

Job Info

• Job Identification 10004
• Job Category Engineering
• Posting Date 02/03/2026, 01:00 AM
• Job Schedule Full time
• Job Shift Day
• Locations Coyol Free Trade Zone, La Garita, Alajuela, CR (On-site)