9 часов назад
Quality Operations Manager (SECOND SHIFT) (MedTech)
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 Operations Manager (SECOND SHIFT) (MedTech): Leading quality assurance programs for medical-device manufacturing at the Horizontes site in Ciudad Juarez with an accent on regulatory compliance, process validation, and continuous improvement. Focus on preparing for FDA and other regulatory audits, resolving non-conformities and CAPAs, managing manufacturing risks, and developing quality performance metrics.
Location: Onsite in Ciudad Juarez, Chihuahua, Mexico; second shift
Company
Johnson & Johnson MedTech develops medical technologies and electrophysiology solutions for the treatment of cardiac arrhythmias.
What you will do
- Lead quality improvement initiatives using PDCA, Six Sigma, Kaizen, Lean techniques, benchmarking, and quality metrics.
- Review and approve Engineering Change Orders, process documentation, validation strategies, PFMEAs, control plans, and manufacturing instructions.
- Ensure compliance with QSRs, ISO 13485, GMPs, production controls, lot segregation, and internal quality procedures.
- Prepare for and participate in FDA and other regulatory or certification audits as a subject-matter expert or escort.
- Direct the investigation and disposition of non-conformities, CAPAs, customer complaints, material segregation, and complex manufacturing quality problems.
- Supervise, mentor, coach, and develop quality personnel while managing departmental resources and budgets.
Requirements
- Degree in mechanical, electrical, industrial engineering, or an applicable science.
- 8–10 years of relevant work experience or demonstrated performance.
- Excellent spoken and written English is required.
- Ability to work with and negotiate with governmental and auditing agencies.
- Strong problem-solving, judgment, communication, leadership, and team-management skills.
- Experience with quality systems, regulatory compliance, quality validation, risk assessments, SOPs, and quality control.
Nice to have
- Master’s degree or doctorate in an applicable science.
- CQA, CQE, CQM, CBA, MBB, or BB certification.
- Active involvement in manufacturing problem-solving and resolution.
- Knowledge of ISO 9001.
Culture & Benefits
- Inclusive work environment focused on respecting individual dignity, diversity, and merit.
- Work within a global medical-technology organization focused on less invasive and personalized treatments.
- Responsibility for health, safety, environmental, regulatory, and company-policy compliance.
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