Quality Engineer, Post Market Surveillance

This position must provide expertise and leadership in the areas of post market surveillance, including root cause analysis, risk assessment, failure mode determination, product reliability and monitoring. This position will work with Development, Operations, Manufacturing, other Quality functional areas along with the global field teams to ensure work is completed in accordance with Inspire procedures and geographic regulations.  In addition, this role must be flexible for changing priorities and able to work without direct supervision.

MAIN DUTIES/RESPONSIBILITIES

• Lead product reporting process (complaint handling) as assigned, for all Inspire products. This may include the initial evaluation, escalation, risk evaluation, investigation, root cause determination, product disposition and report closure.
• Manage the returned product analysis process, including decontamination, external vendor sterilization, root cause analysis and root cause determination along with supporting other root cause analyses as
• Lead failure mode determination, which may include working with external labs.
• Manage and collect data on returned product results as well as post market therapy outcomes stemming from the product reporting process.
• Organize and lead reviews with Development, Operations and Manufacturing on emerging quality issues and participate in any resulting corrective actions.
• Work with Operations to obtain product returns from the field and initiate warranty replacements.
• Lead/participate in post market reviews such as: product performance, therapy performance, safety and system risk management.
• Lead/participate in post market risk management reviews with cross-functional teams to assure risks are minimized and potential CAPAs are initiated.
• Lead/support cross-functional teams to resolve quality issues and complete CAPAs.
• Generate and approve design history file documents, device master record documents, ECOs and other QMS records.
• Support QMS audits with both internal and external auditors
• Ability to perform design reliability, process and product quality assurance functions.

QUALITY SYSTEM RESPONSIBILITIES­

• Document product and therapy related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed.
• Complete training requirements and competency confirmations as required for this position within the required timeline.
• Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement.

QUALIFICATIONS

Educational Requirements:

Required

Bachelor's degree in a technical or scientific field, preferably an engineering discipline such as Electrical, Mechanical, Materials or Biomedical.

Preferred

Master's degree in a technical or scientific field

Required Experience*:

• 1-3 years minimum experience in quality or design function in the finished medical device industry
• Demonstrated team leadership skills and ability to prioritize, execute and report on projects
• Experience with risk management tools such as; dFMEA, pFMEA, and FTA
• Experience with risk management standard ISO14971
• Experience with GHTF requirements for process validations, etc.
• Knowledge on ISO and FDA/Quality System Requirements. (e.g. ISO 13485; ISO 14969; FDA 21 CRF Part 820, 821, 822)
• Strong project and time management skills
• Demonstrated creative and effective problem solving and original thinking for compliance solutions
• Ability to work on multiple tasks concurrently with changing priorities
• Proficient with of MS Word, Excel and PowerPoint

Preferred Experience:

• Experience in design reliability, process and product quality assurance functions
• Experience with Class III active implantables
• ASQ certifications; CRE, CQM, CQE, CQA etc.
• ISO 14971 training
• Experience with industry standards such as; IEC 60601, EN 45502, etc.
• ISO 13485 certified auditor or RAB auditor

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