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2 дня назад

Manufacturing Supervisor (Medical Devices)

70 000 - 88 000$
Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Manufacturing Supervisor (Medical Devices) (Medical Device Manufacturing): Supervising on-site production of regulated cardiac health devices with an accent on production scheduling, quality compliance, team development, and safety. Focus on maintaining FDA and ISO 13485 compliance, supporting CAPA and nonconformance investigations, and driving Lean, 5S, and continuous improvement initiatives.

Location: On-site in Orange County, California, United States; second shift from 3:00 PM to 11:00 PM PST. Regular presence on the manufacturing floor is required, with possible weekend coverage and overtime.

Estimated pay range: $70,000–$88,000 per year.

Company

hirify.global develops digital healthcare solutions using wearable biosensors, cloud-based data analytics, and proprietary algorithms to support cardiac disease detection and prevention.

What you will do

  • Supervise daily manufacturing operations and ensure production schedules, safety requirements, and quality specifications are met.
  • Lead, motivate, train, and develop manufacturing associates while monitoring performance, attendance, and adherence to procedures.
  • Execute production plans, adjust staffing and resources, and coordinate with planning and supply chain to maintain material availability.
  • Ensure accurate production records, deviation reports, maintenance documentation, and Plan vs. Actual performance tracking.
  • Support nonconformance investigations, CAPAs, quality audits, Good Documentation Practices, and data integrity requirements.
  • Drive safety inspections and continuous improvement initiatives, including Lean events, 5S programs, and process standardization.

Requirements

  • Associate degree or equivalent experience required; a bachelor's degree in engineering, manufacturing, or a related field is preferred.
  • 3–5 years of manufacturing operations experience, including 1–2 years in a supervisory or lead role.
  • Experience leading small to medium-sized production teams, preferably in medical device or another regulated industry.
  • Working knowledge of medical device manufacturing, ISO 13485, FDA 21 CFR Part 820, GMP, and related quality systems.
  • Familiarity with ERP or MRP systems such as QAD, SAP, or Oracle.
  • Ability to work on-site in Orange County and cover the 3:00 PM–11:00 PM PST shift.

Culture & Benefits

  • Patient-focused work improving cardiac health outcomes.
  • Collaborative environment focused on learning, feedback, engagement, and accountability.
  • Opportunities to support recruiting, onboarding, employee development, and continuous improvement.
  • Diverse and inclusive workplace with reasonable accommodations for qualified individuals with disabilities.
  • Exempt position with potential weekend coverage and overtime based on production needs.

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