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Operations Director

Company: Alpha-Stim, by Electromedical Products Internation
Location: Fort Worth
Posted on: January 16, 2022

Job Description:

Position Description : Operations Director
Based in Mineral Wells, TX

The Operations Director is responsible for ensuring the company achieves a perfect order rate on its shipments to customers and manages the company's internal production operations and supply chain. Additionally, the Operations Director assists the VP of Engineering on all matters related to the physical design and manufacturability of EPI's medical devices and accessories

Primary Responsibilities:
1. Manage EPI's manufacturing processes
Manage all operations/supply chain staff including production, shipping/receiving, and quality assurance (QA)
Responsible for perfect order rate to customers (on-time shipment of complete orders, defect free)
Ensure timely procurement of vendor-supplied components and accessories
Suggest and implement design and manufacturing improvements to reduce costs and improve quality of devices and accessories

2. Manage EPI internal production quality processes
Ensure EPI's production processes are compliant with US (FDA) and foreign government regulations and documentation and maintain a quality management system, consistent with cGMP or ISO equivalent (ISO 13485)
Collection of data on manufacturing defects and customer returns, root cause analysis of the defects and returns, and recommendations and implementation of solutions to fix root causes
Assist in the preparation for and oversight of third party quality audits of EPI and/or EPI's contract manufacturers and suppliers

3. Oversee vendor production quality and new vendor selection
Assessment and selection of contract manufacturers and suppliers, including component suppliers sourced directly by EPI
Oversight on cost, quality, throughput, and delivery (timing) of contract manufacturers and suppliers (this is capabilities focused, not procurement)

4. Product engineering efforts
Assist the VP of Engineering with design engineering (specifications and engineering drawings), product development processes, and documentation from the beginning concept stage through prototype and first production stages, for existing and new products (in-house and/or third-party management)
Suggest design and/or manufacturing improvements to reduce cost and/or improve quality and/or manufacturability of devices and accessories
Become knowledgeable of Design Control and Design History Files in compliance with government regulations
Assist the VP of Engineering to ensure devices and accessories are compliant with government regulations and ISO standards and meet performance (design and functionality) and cost of production parameters
Assist and provide technical support for the registration of EPIs device worldwide

5. Prepare and manage Operations expense budget

6. Any additional lawfully assigned duties that may be deemed necessary by the President

Supervises: All production staff

Desired Qualifications: The candidate should have:
1. Degreed electrical engineer with 10+ years EMS industry engineering and production leadership experience, particularly with medical devices
2. Experienced in design (layout) and manufacturing of printed circuit boards and related assemblies
3. Experienced in operating in an ISO standards-based environment

Working Conditions: Office environment, excellent corporate culture. Very limited travel. Periodic weekend or evening work is expected.

Keywords: Alpha-Stim, by Electromedical Products Internation, Fort Worth , Operations Director, Executive , Fort Worth, Texas

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