Quality Engineer, Capa Administrator

POSITION SUMMARY

This position must provide expertise and leadership in the area of corrective and preventive action, manufacturing process improvements, quality system requirements and process monitoring. This position will work with Development, Manufacturing, Marketing, Information Systems and other Quality functional areas to ensure work is completed in accordance with Inspire procedures and geographic regulations. This role must be flexible for changing priorities and able to work without direct supervision.

MAIN DUTIES/RESPONSIBILITIES

• Manage corrective and preventive action (CAPA) process for both internal Inspire CAPAs as well as supplier corrective and preventive action requests (SCARs).
• Lead and coach cross-functional teams to resolve quality issues and navigate the CAPA process.
• Monitor CAPA deliverables, CAPA timelines and trend both CAPAs and SCARs.
• Schedule CAPA team meetings and monthly CAPA management reviews.
• Report on CAPA progress at monthly CAPA meetings as well as Quality management reviews.
• Support all aspects of CAPA activity, including CAPA owner assignment, utilization of root cause tools (i.e., 5 whys, Is/Is Not, Ishikawa, etc.), verification of effectiveness checks and Quality approval for CAPA closure.
• Partner with Inspire product quality and manufacturing teams to support supplier corrective actions.
• Provide audit support for both the CAPA and SCAR processes.
• Partner with Material Quality to develop SCAR timelines and process monitors.
• Support non-conformance (NCR) process and process trending.
• Participate in the development of quality work instruction and procedural updates as assigned.

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.

Preferred

• Bachelor's degree in an engineering discipline such as electrical, mechanical, materials, manufacturing or biomedical.
• Master's degree in a technical or scientific field.

Required Experience:

• 2 - 5 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
• 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 MS Word, Excel and PowerPoint

Preferred Experience:

• Experience with Class III active implantables
• Experience with the corrective action process, supplier corrective action requests, nonconformance resolution, field corrective actions and/or product recalls.
• Experience with risk management standard ISO14971 as well as risk management tools such as dFMEA and pFMEA.
• ISO 13485 certified auditor or RAB auditor
• ASQ certifications; CRE, CQM, CQE, CQA etc.

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