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Operations Manager - Medical Device Manufacturing

Location : Bridgewater NJ US 08873
Job Type : Direct
Reference Code : 19056-JZT
Compensation : 130000.00 - 140000.00 USD/YEAR
Hours : Full Time
Required Years of Experience : 5
Required Education : BS Engineering
Travel : No
Relocation : No
Job Industry : Medical Devices

Job Description :

  • Permanent position for an Operations Manager for medical device contract manufacturing.

  • Responsible for contract manufacturing operations to produce a medical device delivery system.

  • Responsible for supply reliability and for implementing the strategic initiatives to continuously improve overall device manufacturing and engineering process quality, safety, compliance and cost.

  • The Operations Manager will lead the organization's activities to commercialize the medical device delivery system.

  • Responsible for achieving device manufacturing and engineering (M&E) operational objectives in support of clinical trial execution, product launch, quality, customer satisfaction, cost and safety.

Required Qualifications :

  • BS Engineering required, MS Engineering preferred.

  • PMP certification a plus.

  • Minimum 2 years in medical device or related industry.

  • Minimum 5 years manufacturing operations, supply chain and project management experience.

  • Demonstrated strong leadership, communication, influencing and collaboration.

  • Experience with advanced project management and project coordination.

  • In depth understanding of cGMP requirements (FDA 21 CFR Part 820), ISO 13485 and other regulatory requirements.

  • Proficiency in using project management and standard office software.

Contact: Jim Terkovich

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