Careers @ MGC Diagnostics

Open Positions

• Position
  Location
  Date Posted
• Quality Systems Analyst

  St. Paul, Minnesota

  5/20/2024

  Primary Purpose

  The Quality Systems Analyst/Auditor is responsible for ensuring that the Quality Management System (QMS) for our medical devices meets the required standards of regulatory bodies, both domestic and international. This role encompasses internal audit activities, external standards management, CAPA ownership and support, label management, and gap assessments related to global medical device regulations.

  KEY RESPONSIBILITIES AND ESSENTIAL FUNCTIONS

  INTERNAL AUDITS:
     - Plan, conduct, and report on internal quality system audits.
     - Coordinate corrective actions and verify their effective implementation in response to audit findings.
     - Maintain and manage the internal audit schedule.

  EXTERNAL STANDARDS MANAGEMENT:
     - Track, analyze, and communicate changes to external standards that impact the medical device QMS.
     - Collaborate with cross-functional teams to ensure alignment with evolving standards.

  CAPA MANAGEMENT:
     - Own and manage the Corrective and Preventive Action (CAPA) process.
     - Support other CAPA owners in the identification of root causes, implementation of corrective actions, and verification of effectiveness.
     - Run periodic reports and analytics on open CAPAs to identify trends and areas of improvement.

  LABEL MANAGEMENT SUPPORT:
     - Serve as a backup for GS1 and GUDID label management processes.
     - Ensure labels are in compliance with relevant regulatory standards.

  REGULATORY GAP ASSESSMENTS:
     - Continuously assess the QMS against global medical device regulations.
     - Identify, report, and mitigate any gaps or non-conformities in the QMS related to global regulations.

  CONTINUOUS IMPROVEMENT:
     - Proactively identify opportunities for process and quality improvements.
     - Collaborate with cross-functional teams to implement enhancements to the QMS.

  QMS TRAINING MANAGEMENT:
     - Annual QMS training
     - Onboard/new employee QMS training
     - Electronic Signature for new employees
     - File ECO’s trainings as applicable

  SUPPORT DOCUMENT CONTROL:
     - Engineering Change Orders
     - Product Analysis/validations
     - Deviations
     - Filing other QMS documentation

  - Accept other responsibilities as assigned.
  - Complete training as identified by standard operating procedures and procedural work instructions.
  - Regular attendance is an essential job function.

  Follow all Company policies and procedures relating to confidential propriety information (CPI) including but not limited to what is outlined in the Confidentiality and Non-Solicitation Agreement.

  If this sounds like a good fit, please consider submitting your resume and cover letter in the form below.

• Manufacturing Quality Engineer

  St. Paul, Minnesota

  5/20/2024

  Primary Purpose

  The Manufacturing Quality Engineer ensures the highest standards of quality and compliance.  The position is vital in overseeing the manufacturing processes to guarantee that all products meet regulatory requirements and company standards.  This position will collaborate closely with production teams and quality assurance personnel to develop, implement, and refine manufacturing quality control systems.

  KEY RESPONSIBILITIES AND ESSENTIAL FUNCTIONS

  NON-CONFORMANCE REPORT (NCR) AND INVESTIGATION:
     - Document and analyze NCR reports from Receiving/ Inspection and Production Departments
     - Perform containment and investigation actions related to non-conforming material/ products that escape production.
     - Prepare and communicate data analysis reports for monthly Product Performance and Quality Management Review meetings.
  
  ​​​​​​PRODUCTION ANALYSIS OF DATA:Production Analysis of Data:
     - Analyze in-process and final checkout yield data. 
     - Develop and provide reports and recommendations for monthly Product Performance and Quality Management Review meetings.
  
  CAPA
     - Ownership and execution of production and vendor related Corrective Actions/ SCARs
     - Identify and recommend preventative actions, including continuous product and process improvement.
  
  RISK MANAGEMENT:
     - Collaborate with Risk Management Team to develop and maintain PFMEAs.
  
  DESIGN ASSURANCE:​​​​​​​
     - Review and consult with Project Teams during the development process to ensure Company Design and Development procedures are followed through documentation audits and design reviews.
  
  ​​​​​​​AUDIT:​​​​​​​
     - Support the execution of quarterly UL Audit and Annual Surveillance/ Recertification assessments by Notified Body.
     - Assist QARA team with auditing of suppliers.
  
  - Accept other responsibilities as assigned.
  - Complete training as identified by standard operating procedures and procedural work instructions.
  - Regular attendance is an essential job function.
  - Follow all Company policies and procedures relating to confidential propriety information (CPI), including what is outlined in the Confidentiality and Non-Solicitation Agreement.

  Job Requirements

  Must Have – Minimum Requirements
     - Bachelor’s Degree in Technical, Scientific, or Engineering discipline
     - 5-7 years of experience in Quality Engineering, Design Assurance, or other Quality Systems role.
            -Experience in Medical Devices or other regulated industry preferred
     - Knowledge of ISO 13485, ISO 14971, IEC 60601, and other Medical Device related standards.
     - Process-oriented problem solver and strong documentation creation/ management experience.

  Nice to Have
     - Audit experience (both as auditee and auditor)
     - Lean/ Six Sigma certification

  Working Conditions or Physical Requirements

  - Will be required to regularly sit for extended periods of time; use hands and fingers, handle or feel objects, talk, hear and see.
  - Occasionally lift and/or move up to 25 pounds, stand, walk, climb, balance, stoop, kneel, crouch, or reach with hands and arms.
  - The environment is fast-paced; time pressured and requires accuracy.
  - Will be required to regularly multi-task between projects, move throughout the office building and effectively communicate.
  - The normal environment is quiet and typical of an open office setting with some areas that may be louder at times; along with time spent on the production floor, where environment can be louder due to equipment running.

  If this sounds like a good fit, please consider submitting your resume and cover letter in the form below.

• Regulatory Affairs Analyst

  St. Paul, Minnesota

  5/20/2024

  Primary Purpose

  The Regulatory Affairs Analyst will ensure compliance to applicable quality and regulatory requirements.  This role manages support of vital regulatory tasks including complaint processing, post-market surveillance, and recall/ adverse event reporting.  The Analyst supports regulatory activities across pre- and post-market phases and conducts regulatory gap assessments to mitigate compliance risks.

  KEY RESPONSIBILITIES AND ESSENTIAL FUNCTIONS

  COMPLAINT PROCESSING:
     - Investigate and document customer complaints to identify quality issues and ensure compliance with applicable regulatory standards.
     - Collaborate with cross-functional teams to analyze root causes and implement corrective actions to prevent recurrence of issue
  
  POST MARKET SURVELLIANCE:
     - Monitor and analyze post-market data to assess the safety and effectiveness of medical devices throughout their lifecycle.
     - Prepare and review periodic reports on product performance, identifying trends that may require regulatory action or product improvements.
  
  RECALL/ADVERSE EVENT REPORTING:
     - Coordinate the timely reporting of adverse events and potential recalls to regulatory authorities, ensuring compliance with legal obligations.
     - Evaluate incident reports to determine the necessity for corrective actions and facilitate the execution of recall strategies, if required.
  
  PRE-MARKET REGULATORY SUPPORT:
     - Assist in preparing regulatory submissions for new products or changes to existing products, ensuring all necessary documentation meets regulatory standards.
     - Conduct thorough reviews of product labeling and marketing materials to guarantee compliance with regulatory requirements before market launch.
  
  POST-MARKET REGULATORY SUPPORT:
     - Provide ongoing regulatory advice and updates to ensure continued compliance of products with international standards and regulations post-launch.
     - Engage in continuous improvement initiatives by reviewing and updating regulatory strategies and documentation in response to evolving regulatory landscapes.
  
  REGULATORY GAP ASSESSMENTS:
     - Continuously assess the QMS against global medical device regulations, with a primary focus on the EU Medical Device Regulation (EU MDR).
     - Identify, report, and mitigate any gaps or non-conformities in the QMS related to global regulations.
  
  CONTINUOUS IMPROVEMENT:
     - Proactively identify opportunities for process and quality improvements.
     - Collaborate with cross-functional teams to implement enhancements to the QMS.
  
  - Accept other responsibilities as assigned.
  - Complete training as identified by standard operating procedures and procedural work instructions.
  - Regular attendance is an essential job function.
  - Follow all Company policies and procedures relating to confidential propriety information (CPI) including but not limited to what is outlined in the Confidentiality and Non-Solicitation Agreement.

  Job Requirements

  Must Have – Minimum Requirements
     - Bachelor’s Degree in Technical, Scientific, or Engineering discipline
     - 5-7 years of experience in Quality Assurance, Regulatory Affairs, or other Quality Systems role, preferably in medical device or other regulated industry.
     - Knowledge of ISO 13485, MDSAP, EU MDR, UK MDR and other global regulatory requirements.
     - Process-oriented problem solver and strong documentation creation/ management experience.

  Nice to Have
     - Audit Experience (both as auditee and/or auditor)

  Working Conditions or Physical Requirements

  - Will be required to regularly stand for extended periods of time; use hands and fingers, handle or feel objects, talk, hear, and see.
  - Occasionally lift and/or move up to 50 pounds, stand, walk, climb, balance, stoop, kneel, crouch, or reach with hands and arms. Requires repetitive motion and manual dexterity. 
  - The environment is fast paced; time pressured and requires accuracy.
  - Will be required to regularly multi-task between projects, move throughout the office building and effectively communicate.
  - The normal production environment can be louder due to equipment running.

  If this sounds like a good fit, please consider submitting your resume and cover letter in the form below.

• Manufacturing Assembler

  St. Paul, Minnesota

  4/24/2024

  Primary Purpose

  Responsibilities will include product assembly, testing of sub-assemblies and final system checkout for all products, both pulmonary function and gas exchange. Develop, implement, and maintain manufacturing procedures which support quality objectives and build schedule objectives. Ensure continuity of quality processes in the manufacture of MGC products.

  KEY RESPONSIBILITIES AND ESSENTIAL FUNCTIONS

  - Support team in manufacturing of sub-assembly, final assembly, and testing of all MGC products as requested.
  - Perform QC system checkouts on MGC products as required.
  - Read Schematics and use electronic test equipment to troubleshoot sub and final assemblies.
  - Ensure that GMP compliance is met at all stages of production.
  - Monitor WIP to ensure:
         - Work order shortages are minimized, confer status with Production Manager
         - WIP and stock inventories are accurate.
         - Work is available for team members when they will need it.
  - Perform manufacturing training including:
         - Soldering
         - Crimping
         - Sealants and thread lockers
         - ESD practices and standards
  - Aid in the writing and implementation of ECOs and deviations
  - Maintain a clean and safe work area.
  - Accept other responsibilities as assigned.
  - Complete training as identified by standard operating procedures and procedural work instructions.
  - Regular attendance is an essential job function.
  - Follow all Company policies and procedures relating to confidential proprietary information (CPI) including, but not limited to, what is outlined in the Confidentiality and Non-Solicitation Agreement.

  Job Specifications:

  - Minimum 2-year electronics degree or equivalent
  - Bachelor of Science in Electrical Engineering preferred, with experience of manufacturing and testing on equipment.
  - Be able to respond purposefully and handle stress in all circumstances.
  - Proficiency with the MRP database to perform the following:
         - Find part numbers and stock locations.
         - Transaction History
         - MRP Details
         - Review Shortages
         - Inventory control
         - Post operation completion
  - Be an independent self-starter with attention to detail.
  - Proven ability to meet deadlines and set goals.
  - Have sufficient skill and proficiency to train employees in the following areas:
         - Soldering practices / standards
         - Thread sealant / locker practices / standards
         - ESD practices / standards
         - All MGC product checkouts and assembly.
  - Ability to accurately read schematics.
  - Proficiency in use of test equipment.
  - Ability to effectively communicate in English. Excellent written and verbal communications skills and interpersonal skills.
  - Strong problem solving and troubleshooting skills.

  Working Conditions or Physical Requirements: 

  - Will be required to regularly sit for extended periods of time; use hands and fingers, handle or feel objects, talk, hear, and see. Occasionally lift and/or move up to 50 pounds, stand, walk, climb, balance, stoop, kneel, crouch, or reach with hands and arms. The environment is fast paced; time pressured and requires accuracy. Will be required to regularly multi-task between projects, move throughout the office building and effectively communicate. The normal environment is typical of an operations environment with areas that can be louder due to equipment running.
  - Some overtime required.
  - Maintain a clean work environment.

  If this sounds like a good fit, please consider submitting your resume and cover letter in the form below.

• Field Service Engineer

  Denver, CO Area

  4/9/2024

  Primary Purpose

  Provide technical support and service for all MGC Diagnostics’ systems as well as new products and product revisions by providing on-site remedial service, preventative maintenance, product installation, product recertification and upgrades.  The FSR can assist customers and bio-medical engineers who need technical assistance.  Meets standards set by Field Service Manager for improving customer satisfaction and reducing warranty expenses and advises design engineering, as requested to produce the most serviceable and maintainable products consistent with corporate objectives.

  KEY RESPONSIBILITIES AND ESSENTIAL FUNCTIONS

  - Interface with Field Service Support Team, and Field Service Manager to provide prompt, courteous and effective service support to MGC Diagnostics customer base.
  - Complete documentation of service calls and transfer reports to MGC Diagnostics Field Service Support Center.
  - Relay updates regarding customer database changes regarding equipment, location, operators or accounting information.
  - Interface with Field Service Support Team, Product Managers, Quality Assurance and Technical Support with input for new products and product revisions to ensure requirements for documentation and serviceability are met.
  - Control service inventories assigned and ensure all equipment sent to customer is returned.
  - Provide service and sales management with timely written reports on progress, recommendations and concerns.
  - Fills out and completes all assigned open cases in CRM in a timely (weekly) fashion. Finished expense reports quickly and efficiently in a timely (weekly) fashion.
  - Monitor travel expenses to maintain high efficiency and low cost to meet financial goals.
  - Continually monitors personal expenses maintaining high efficiency and low cost as daily goals.
  - Communicate effectively with service team and sales support to ensure travel schedule is effective, efficient and customers are satisfied.

  Job Requirements

  - BSEE or Bio-med degree or minimum 2-year degree in electronics or related field.
  - Minimum of 2 years field service experience servicing medical equipment.
  - Excellent communication skills.
  - Ability to interact positively under all situations. 
  - Trouble shooting and problem solving abilities. 
  - High computer efficiency. 

  Working Conditions or Physical Requirements

  - Must be able to lift 50 pounds, and maneuver MGC Diagnostics Equipment.
  - Must be able to bend, stoop, crouch, be on the floor, or other position as needed while performing service on equipment.
  - Must be attentive and focused.
  - Must be able to travel both in and out of state for service requests via vehicle or airlines from major airport. Travel could be overnight or several hours away from starting location.

  Benefits:
  - 401(k)
  - 401(k) matching
  - Dental insurance
  - Employee assistance program
  - Flexible spending account
  - Health insurance
  - Health savings account
  - Life insurance
  - Paid time off
  - Vision insurance

  Experience level: 2 years

  Schedule: Monday to Friday

  Work setting: Clinic

  Ability to Relocate: Denver, CO: Relocate before starting work (Required)

  Willingness to travel: 100% (Required)

  If this sounds like a good fit, please consider submitting your resume and cover letter in the form below.