**23-month fixed term contract**
Fully onsite in Carrigtwohill
Provide quality engineering support and direction in quality assurance, control and preventative activities within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes. Advocate and lead the execution of initiatives & projects to enhance quality performance within the business. Ensure compliance to regulation and standards.
• Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following:
• Work closely with operations and the business functions to ensure quality performance of product and processes.
• Oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities.
• Lead and participate in the development and improvement of the manufacturing processes for existing and new products.
• Analysis and review of concession requests.
• Review and approval of change management activities.
• Maintain KPI for monitoring of process quality, perform analysis and interpret trends, take action as necessary.
• Support execution and analysis of QATs.
• Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.
• Proficient in risk management practices and tools, having high expertise in • process risk. Develop and provide input for risk management by identifying opportunities and weaknesses.
• Proficiency in and makes continuous strides towards optimization of inspection methods and sampling. Support First Article Inspections.
• Proficiency in statistical methods and application.
• Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise.
• Assist in the development, responsible for review & approval of process and equipment validation/qualification.
• Support manufacturing transfers to other plants/facilities, leading quality activities.
• Responsible for initiation, management and support of Ship, Product Holds, potential product escapes.
• Coach and mentor others in quality topics and activities.
Qualifications Knowledge Skills
• Bachelor degree in Science, Engineering or equivalent/ related subject and 2 or more years of work experience in a quality discipline,
• Previous experience in a regulated environment desirable.
• CQE or equivalent course work / experience desirable
• Proficient in understanding of Med Device manufacturing processes desirable.
• Familiarity with ISO 13485, GDP, GMP desirable.
• Lean Six Sigma training a distinct advantage.
• Excellent communication skills and attention to detail.
• Have a good understanding of engineering and quality practices & methods.
• High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
• Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
• Must be willing to work as part of a multi-site team, with some travel required.
• Working knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs.
• Highly developed problem solving and strong analytical skills.
• Builds strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach
• Is diplomatic, tactful and leverages excellent interpersonal keys to help achieve outcomes.
• Manages change well and adopts a continuous improvement orientation to the role
• Excellent English (both oral and written)
• Ability to be the voice of Quality when dealing cross functionally
Skills Required
- Bachelor degree in Science, Engineering or equivalent and 2+ years experience in a quality discipline
- Working knowledge/experience of Risk Based and statistical techniques (process risk, statistical sampling plans, Process Capability, Gauge R&Rs)
- Proficiency in statistical methods and application
- Experience overseeing and approving NC & CAPA, root cause analysis and problem solving
- Experience with change management, concession review and approval, and process/equipment validation/qualification
- Advocate/proficiency in Human Factors identification and mitigation
- Experience participating and interfacing in internal and external regulatory audits
- Proficient with Microsoft Word, Microsoft Excel and PowerPoint
- Ability to coach and mentor others in quality topics and activities
- Excellent communication skills, attention to detail and excellent English (oral and written)
- Self-starter with analytical and problem solving skills and ability to handle multiple tasks
- Must be willing to work as part of a multi-site team (some travel required)
- Previous experience in a regulated environment (desirable)
- CQE or equivalent coursework/experience (desirable)
- Proficient understanding of medical device manufacturing processes (desirable)
- Familiarity with ISO 13485, GDP, GMP (desirable)
- Lean Six Sigma training (distinct advantage)
Inari Medical Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Inari Medical and has not been reviewed or approved by Inari Medical.
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Fair & Transparent Compensation — Pay is considered competitive for many roles, with employees described as 'extremely happy' with total compensation including pay, stock, equity, and benefits. Feedback suggests above‑average salary levels across departments contribute to strong pay sentiment.
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Healthcare Strength — Benefits include comprehensive medical, dental, and vision coverage, with 100% employer‑paid premiums for employees cited in multiple descriptions. Additional options like critical illness, accident, hospital indemnity, and wellness programs reinforce the healthcare offering.
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Leave & Time Off Breadth — Time off is characterized by unlimited PTO, cited as a top benefit by employees. Paid holidays and flexible hours are also referenced, expanding the range of time‑off options.
Inari Medical Insights
What We Do
Inari Medical, Inc. is a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases.
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