Careers

3 Vacancies At Sensogram Technologies

Oct 8, 2019
Sensogram Technologies

 

Manufacturing Manager 



Job Responsibility Summary:

The Manufacturing Manager reports to the Chief Operating Officer and is responsible for the management of all manufacturing activities including procurement of materials, production planning, supplier controls, training of assembly personnel, packaging and shipping.  Ensures compliance with ISO13485 quality system

Job Responsibility Details:

  • Reports and takes direction from the Chief Operating Officer
  • Responsible for the output and overall quality of the manufacturing process
  • Designs and implements a medical device compliant manufacturing process
  • Manages manufacturing facilities including pest control, air quality, heat, humidity and overall cleanliness
  • Creates and manages materials supply to support sales short and long term forecast.
  • Manages materials Incoming Inspection activities
  • Creates daily, monthly and quarterly production schedule.
  • Manages Supplier Controls to ensure materials meet quality and performance specification. Conducts annual Supplier audits.
  • Hires, trains, manages and supervises manufacturing personnel.
  • Supervises product assembly activities
  • Manages final acceptance testing activities
  • Manages final packaging and shipping activities
  • Participates in Corrective Action / Preventative Action activities
  • Participates in Non-Conforming Parts investigations.
  • Participates in Customer Complaint activites
  • Collaborates with Manager Quality Systems to ensure compliance with ISO 13485 Quality Management System (QMS) for medical device companies

 

Location:  This position is based in Yerevan, Armenia with occasional travel to suppliers for quality audits and corporate offices in Plano, Texas USA. 

Job Qualifications:

  • Minimum of 4-year degree in an engineering related field.
  • Should have related experience in medical device and quality environment.
  • Competency in supervisory management and problem-solving skills.
  • Should have experience with medical device manufacturing
  • Competency in interpersonal skills with diverse workforce. Written and verbal skills must be excellent.

     

    Training:

  • Training may be defined by Chief Operating Officer based on job assignments.
  • Additional training may be required based on job responsibilities and Competence, Awareness and Training procedure.
  • HIPAA training is required.

 

Quality Manager

Job Responsibility Summary:

The Quality Manager reports to the Global VP Quality and Regulatory and is responsible for enforcing and implementing the Sensogram Inc quality management system. The Quality Manager carries out duties for Quality Control, Quality Assurance, and Regulatory departments.

 

Job Responsibility Details:

  • Implement quality activities required to obtain and maintain ISO 13485 QMS certification.This includes correspondence for changes to the business or products including audits by ISO registrar. Quality Manager will work with the Global VP Quality and Regulatory regarding FDA regulatory correspondence for changes to the business or products as well as regulatory audits by the FDA as well as FDA registration and listing deliverables.
  • Manages and Maintains QMS documentation through Greenlight.guru.
  • Completes all Quality Records in manufacturing including, overseeing fixture calibrations and preventative maintenance, reviewing production travelers and maintaining the device history records.
  • Executes tasks that are overseen by the Global VP Quality and Regulatory, including evaluating regulatory changes, participating in Management Review meetings, etc..
  • Execute tasks for the Quality Management System department including documentation control, quality training, internal and supplier audits, and all aspects of customer support complaint communication process including CAPAs, complaints and recalls. These responsibilities are executed under the oversight of the Global VP Quality and Regulatory.
  • Executes duties as part of Design Control project management system.This includes supporting the construction of all Design History Files needed for FDA submissions. Collaborates with other departments (i.e. Development and Marketing) to execute tasks as needed.
  • Responsibilities may include project definition, program management, product integration and system implementation by working with design engineers, product developers, clinical professionals, and customers.
  • Support customer service for complaint handling and notify Regulatory of any adverse events.
  • Support the implementation of short- and long-range departmental goals, objectives, policies, and operating procedures as part of Management.
  • Support and guide individuals and departments in the establishment, use, and continued improvement of the Quality Management System.

 

Location:  This position is based in Yerevan, Armenia with occasional travel to suppliers for quality audits and corporate offices in Plano, Texas USA.

 

Job Qualifications:

  • Minimum of 4-year degree in an engineering related field.
  • Should have related experience in medical device and quality environment.
  • Competency in project management and problem solving skills.
  • Should have experience with medical device registration projects
  • Competency in interpersonal skills with diverse workforce. Written and verbal skills must be excellent.

     

    Training:

  • Training may be defined by Global VP Quality and Regulatory based on job assignments.
  • Additional training may be required based on job responsibilities and Competence, Awareness and Training procedure.
  • HIPAA training is required.

 

Customer Service Manager: 

Job Responsibility Summary:

The Customer Service Manager Reports to the Chief Operating Officer and is responsible for all customer support activities including sales support for product inquiries, product support fielding questions from customers, and customer complaint activities.  Ensures compliance with ISO13485 quality system.

Job Responsibility Details:

  • Reports and takes direction from the Chief Operating Officer
  • Responsible for the timely response and quality of content for customer facing activities
  • Manages external services for off-hour support
  • Develops, or contracts with call center, metrics including logs for all incoming calls
  • Creates scripts of frequently asked questions.
  • Records and reports to the Manager Quality Systems any customer complaints
  • Participates in the investigation and reporting of customer complaints
  • Collaborates with Manager Quality Systems to ensure compliance with ISO 13485 Quality Management System (QMS) for medical device companies

 

Location:  This position is based in the corporate offices in Plano, Texas USA. Some travel may be required to support customer facing activies.

 

Job Qualifications:

  • Minimum of 4-year degree in a medical field familiar with vital signs monitoring or related field. Nursing degree with strong technical foundation is acceptable.
  • Should have related experience in medical device and quality environment.
  • Competency in problem-solving skills.
  • Strong verbal and written communications skills
  • Competency in interpersonal skills with diverse customer base.

Training:

  • Training may be defined by Chief Operating Officer based on job assignments.
  • Additional training may be required based on job responsibilities and Competence, Awareness and Training procedure.
  • Additional training in regulatory compliance relating to Customer Complaints and Post Market Surveillance may be required.
  • HIPAA training is required.

APPLICATION PROCEDURES:  Interested candidates are welcome to send their CV to: [email protected] mentioning the position title in the subject line of the email.

Please clearly mention in your application letter that you learned of this job opportunity through Repat Armenia and mention the URL of its website - www.repatarmenia.org, thanks.

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