6 дней назад
Quality Manager (Medical Devices)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Manager (Medical Devices): Directing quality assurance programs and manufacturing quality operations for electrophysiology medical devices in Costa Rica with an accent on regulatory compliance, process improvement, and product quality. Focus on managing CAPAs and non-conformities, preparing for FDA and other regulatory audits, approving validation and risk assessment strategies, and leading quality teams.
Location: Grecia, Costa Rica; onsite
Company
Johnson & Johnson MedTech develops innovative, less invasive, and personalized healthcare solutions, including electrophysiology products for cardiac arrhythmia treatment.
What you will do
- Direct quality assurance programs supporting manufacturing lines, inspections, operator certification, and production quality standards.
- Lead continuous improvement initiatives using PDCA, Six Sigma, Kaizen, Lean techniques, benchmarking, and quality metrics.
- Manage product quality activities, including non-conformities, CAPAs, customer complaints, material segregation, defect classification, and complex manufacturing problems.
- Lead compliance activities and regulatory audit preparation, including participation as a subject matter expert or escort for FDA and other audits.
- Approve validation plans, PFMEAs, control plans, process instructions, change requests, and risk assessments.
- Supervise, coach, and develop quality engineers, team leaders, supervisors, technicians, and other associates while managing departmental budgets and operational performance.
Requirements
- Bachelor’s degree in science; a bachelor’s degree in engineering is preferred. A master’s degree is preferred.
- 6–8 years of related experience in a regulated environment and at least 3 years of supervisory experience.
- Experience in the medical device industry or medical field.
- Fully bilingual in Spanish and English, with strong technical writing, communication, negotiation, and interpersonal skills.
- Knowledge of QSRs, ISO standards, quality management systems, GMP, statistical analysis, and analytical problem solving.
- Advanced computer and software application skills, together with leadership and conflict-resolution capabilities.
Nice to have
- CQA, CQE, CQM, CBA, MBB, or BB certification.
- ISO Certified Lead Auditor certification.
Culture & Benefits
- Inclusive work environment centered on individual dignity, diversity, and merit.
- Work aligned with Johnson & Johnson’s Credo and Leadership Imperatives.
- Opportunity to contribute to healthcare innovation and products addressing cardiac arrhythmias.
- Responsibilities include compliance with health, safety, environmental, and corporate policies.
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