Principal Quality Systems Engineer

Mainstay Medical is a medical device company focused on marketing an innovative implantable neurostimulation system, ReActiv8®, for people with disabling chronic mechanical Low Back Pain. The company is headquartered in Dublin, Ireland, with subsidiaries operating in Ireland, the United States, Australia, Germany, and the Netherlands.

The Role

The Principal Quality Systems Engineer is responsible for the application and maintenance of quality standards and the quality management system as they apply to products and services of the company both nationally and internationally.  Assists the Quality leadership in the establishment and maintenance of the quality system.  Proactively communicate quality status to management.

The Principal Quality Systems Engineer will work closely with colleagues across multiple time zones around the world.  The quality systems engineer will have regular contact with and may support regulatory, product development/operations and clinical groups.  The principal quality systems engineer is a key point of contact for Quality Specialist/ Document Control, and in approving and managing vendor interactions relating to quality systems software/database(s) utilized to manage product compliance.

The Principal Quality Systems Engineer works with minimal supervision and manages their own tasks.  Communicates organization of tasks to ensure alignment with business priorities.

Position Responsibilities:

• Quality System Responsibilities

• Establishes product quality documentation system by writing and updating quality assurance procedures to maintain compliance to FDA 21CFR820, ISO13485, and other regulatory requirements.  Systems include (but not limited to): Change Management; Document and Record Control; Complaints; CAPA; Audits; Training; Data Analytics and Trending; Management Review.
• Assist management in development of Quality Program Plan(s) and subsequent revisions.  Assist in defining/developing Quality Program status indicators, performance measurements and reporting requirements.
• Own the respective QMS architecture and system processes for number of sub-processes (documentation control, change management, training, metrics management etc. as applicable),   Responsible for the management and reporting of key performance indicators (KPI) of those quality system process/sub-processes.
• Support and execute change notices within the Document Controls system (Grand Avenue Software) ensuring appropriateness and effectiveness. Activities may include performing gap analyses of current and new versions of the software and where appropriate develop verification and validation protocol plans and reports. 
• Perform internal audits to assess compliance to Standards and to the internal Quality System, including investigation, presentation of observations and findings, and reporting.
• Provides assistance to Quality Specialists and Document Control team members as appropriate.
• Support initiatives to drive simplification and integration of quality system requirements and business processes to ensure compliance and facilitate global business growth 
• Escalate areas of non-compliance, risk and/or potential improvement to Management and develop plans for appropriate action to address causes of deficiencies. Identify and investigate potential trends for improvement initiatives.
• Establish, review and maintain department procedures and policies.
• Perform periodic trend analysis of various quality system elements to identify opportunities for improvement and provide inputs to Management Review.
• Provide internal and external audit support as a front-room or back-room lead and/or subject matter expert.
• Quality Engineering Support
  • Ensure engineers have access to the most current external standards and/or guidance; and manage and ensure gaps are identified and appropriately addressed.
  • May provide quality assurance review for design control documents such as validation plans/reports and all associated documents are captured.
  • May assist in management of supplier-related CAPAs (SCARs) as deemed appropriate.
• General Responsibilities
  • Complies with the policies, procedures and work instructions of Mainstay Medical and its subsidiaries.
  • Leads by example in complying with the policies, procedures and work instructions of Mainstay Medical and its subsidiaries.
  • Direct interactions with FDA, Notified Body, other agencies and vendors during company audits/inspections.  
  • Thoroughly document all issues related to quality assurance, GMP, and ISO compliance.  

Qualifications: 

• Bachelors degree in life sciences or engineering discipline required.
• 8 years experience in related med device engineering roles
• ASQ and / advanced degree preferred 

The salary range for this position is $110,000 to 144,000/year; however, base pay offered will take into account a range of factors, including job-related knowledge, skills, and experience. The total compensation package includes a range of medical, dental, vision, financial, and other benefits, as well as equity.

Mainstay Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to gender, race, color, religious creed, national origin, age, sexual orientation, gender identity, physical or mental disability, and/or protected veteran status. Mainstay Medical participates in E-Verify.