Current Opportunities

Quality Engineer IV

The candidate will be working in a high-paced startup environment, which will require the individual to cover multiple functions and have a solid ability to introduce an effective quality culture.

The candidate will help create, monitor, and improve ISO 13485 and 21 CFR 820 quality system procedures to ensure compliance requirements are met efficiently and effectively and in support of company objectives. In addition, as a quality team member, the candidate will provide QMS support for all departments taking on roles in several areas to support monitoring and advancing the system’s needs.

Duties will include:

  • Implement and maintain quality systems, policies, and procedures that ensure compliance with ISO 13485, cGMP, FDA (i.e., 21 CFR part 11, 21 CFR part 803, 21 CFR part 806, 21 CFR part 820, 21 CFR 822), and other applicable standards.
  • Activities include authoring, issuing, and reviewing regulated documents and ensuring processes and products comply with current Good Manufacturing Practices and 21 CFR 820.
  • Quality assurance support in the design and development of medical device products, facilitating the application of design/change controls, risk management, quality plan, and implementation of design and development plan.
  • Provide QA support for internal Quality Systems growth.
  • Collect, validate, and control QMS and production records, including storage and quality management reporting.
  • Manage and maintain the feedback and complaints system and drive issues towards the correct solution path, which may include, as needed, MDR communication to the FDA.
  • Ensure purchased materials meet or exceed quality specifications by performing inspection for acceptance. Complete and maintain all required inspection documentation records for evidence.
  • Support Calibration System and coordinate with the vendor as needed.
  • Review and approve project documents to ensure adequate coverage for the project’s defined scope.
  • Knowledge of cGMP, FDA/EMA regulations.
  • Support regulatory inspections by FDA and foreign regulatory agencies.
  • Other duties as needed.

Experience:

  • BS in Engineering (or equivalent) and a minimum of 6 years experience in the regulated medical device industry as a Quality Assurance Engineer supporting new product development is preferred.
  • Excellent Quality System knowledge required. Practical experience with ISO 13485, FDA Quality System Regulations, Good Manufacturing Practices, Good Documentation Practices, ISO 14971, and other applicable standards.
  • Knowledge of principles, concepts, and practices for design and development activities, Risk Management, FDA 510(k) submissions, and ISO Regulations.

Functional/Technical Knowledge, Skills, and Abilities Required:

  • A minimum of 3 years experience in technical writing to support Quality Management System documentation.
  • Ability to read and understand drawings and perform inspections.
  • Advanced proficiency in Microsoft Office products.
  • Excellent communication (written and verbal) skills.
  • Excellent organization skills.
  • Must be able to work independently and in a team environment.
  • Visual acuity and normal “color vision” to read drawings

ADDITIONAL SKILLS DESIRED BUT NOT REQUIRED

  • Database development using Microsoft Access or compatible.
  • Familiarity with performing Software design reviews to support verification and validation.

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

APPLY HERE

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