Current Opportunities

Document and Data Control Specialist

Position Summary:

  • The Document and Data Control Specialist is responsible for performing the review, processing, and release of quality management system documentation and engineering project documentation.
  • Documentation will be provided by different organizations which will be evaluated for compliance to the systems. A Good Documentation review will be performed to complete the evaluation
  • The documents will be processed through a system of scanned records which are stored in system designated locations to support the QMS, DHF, or DMR.

Key Duties and Responsibilities:

  • Manage, store, and track company documents for both the Quality Management System and engineering projects.
  • Responsibility for validation and revalidation activities for the documentation software systems.
  • Administer the PLM or eQMS system and DocuSign systems as they evolve and change.
  • Administer all users and control levels of the software.
  • Ensure all controlled documents follow the correct routing guidelines.
  • Ensure all documents are routed and approved within the appropriate timeframe.
  • Perform all training for eQMS or PLM systems and activities.
  • Monitor document lifecycles to ensure appropriate and necessary reviews are conducted.
  • Ensure documents are regularly reviewed based on system guidelines.
  • Assist in preparing, providing, and/or retrieving documents as needed for internal or external audits.
  • Track, trend, and report status of deviations and change orders as needed.
  • Issue and track controlled copies of documents for the system and supporting production.
  • Communication of all changes and releases of the QMS to the company.

Training and Skills:

  • Minimum 3 years of industry related experience with high-level use of a PLM or eQMS including experience of software implementation in a regulated industry.
  • Excellent technical writing skills
  • Must be proficient in using Microsoft Word and Excel. Specialist should be proficient with computers to support proper records storage and archiving.

Surround Medical Systems, Inc is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.

Primary Work Location:   USA Morrisville, NC – onsite

Reports to: Director, Quality Management Systems

Authorized to work in the US

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Recently Filled Opportunities

Receiving Inspector

Job Description:

  • The quality Receiving Inspector is responsible for performing visual and dimensional inspections on manufactured parts, assemblies, and/or sub-assemblies. All inspections will be documented for traceability as well as supplier performance reporting.
  • Parts will be inspected to engineering drawings, the purchase order(s), industry standards, and specifications.
  • The Inspector will be required to report inspection accept/reject information directly to company departments. Rejections will be managed through the nonconforming materials process.

Requirements:

  • Candidate must have practical experience performing the incoming inspection on complex machined parts, assemblies, and/or sub-assemblies.
  • The inspections will be performed to engineering requirements specified within published inspections plans.
  • The ideal candidate will have a minimum of five years of experience performing inspections in an electro-mechanical manufacturing environment.
  • Must be proficient in using Microsoft Word and Excel. Inspector should be proficient with computers to support proper records storage and archiving.
  • Must have experience in supporting nonconforming material processes.
  • Run already programmed CMM inspections. The ability to program CMM is a plus.
  • Maintain fixtures and tools for inspections.
  • Release inspected inventory to the stockroom or production floor as needed.
  • Support NCM activities, including investigations.
  • Support manufacturing in-process and final inspections and necessary records. Knowledge of FDA Good Documentation Practices desired.

Required Skills:

  • Minimum 5 years of hands-on mechanical inspection experience in the manufacturing industry.
  • Experience inspecting complex custom machined/fabricated parts.
  • The candidate must have a strong knowledge using various mechanical inspection tools, such as micrometers, calipers, pin gauges, telescoping gauges, tape measures, and depth gauges.
  • Knowledge of tight tolerance is required.

Surround Medical Systems, Inc is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.

Primary Work Location:   USA Morrisville, NC – onsite

Reports to: Director, Quality Management Systems

Authorized to work in the US

Manager, Service Operations

Position Summary:

The Manager of Service Operations is responsible for coordinating the installation, maintenance and warrantee claims of the Surround Medical Systems.  Responsible for building a new Service Operations department for Surround Medical.  Coordinates and organizes all necessary resources of a third-party installation and service provider and manages customer support service and service field operation resources to meet commitments.  Oversees the implementation of medical systems, supports multiple implementation projects, reviews customer product demands, develops project plans and ensures that implementations are completed on time, within budget, and meet customer and business expectations.

Key Duties and Responsibilities:

  • Coordinates with third party service providor all system installation and field seervice activities. Develops installation templates, defines time-lines and identifies task owners.  Interacts with the appropriate Field, Manufacturing, Engineering, Supply Chain and Home-office personnel to ensure completeness of installation plans and activities.  Communicates and distributes installation information to all affected individuals.  Tracks and drives completion of tasks, and alerts/escalates potential failures to appropriate management personnel.
  • Acts as point-of-contact for the field service and customer regarding status of installation timelines and real-time product ship information. Acts as facilitator and point-of-contact for cross-functional teams created to assist with product installations.
  • Key point of contact to understand issues with new installations and technical escalations to ensure functional support areas are properly engaged through resolution.
  • Tracks products per 21CFR requirements and ensures full traceability for customer systems and replacement parts. Adheres to strict guidelines for adverse events and reporting per 21CFR requirements.
  • Quickly addresses customer concerns and questions with exceptional follow up and responses.
  • Monitors schedule completion identifies shortfalls and tracks through completion
  • Utilizing automated tools creates, monitors and reports a series of metrics with respect to all service deliverables. These metrics are used to improve overall team performance, determine areas of opportunity and adhere to FDA audits and reporting.
  • Contributes to team efforts by accomplishing related results in a cooperative and supportive manner.

Education Qualifications:

  • Bachelor’s degree or greater

Training and Skills:

  • 5+ years in service operations management
  • Medical device service/installation experience preferred.
  • Excellent verbal and written communication skills; good presentation skills; good interpersonal/customer relations skills.
  • Excellent analytical, planning, organizational, and project management skills; receptive and supportive of team efforts.
  • Ability to persuade/influence others in sensitive/confrontational situations.

Surround Medical Systems, Inc is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.

Primary Work Location:   USA Morrisville, NC – onsite

Reports to: Senior Vice President

Authorized to work in the US