- Ownership for site quality performance and measurement including KPI’s and participate in supplier performance reviews.
- Support quality issues with site & partner with Internal Customers; Lead effective supplier containment and corrections/corrective actions
- Hands on experience of PPAP associated with New Product Launches and Management of Production cycles there after (Manufacturing Transfers).
- Participate in cross-functional teams in the development of new products or changes related to current products in meeting customer requirements.
- Applies sound, systematic problem-solving methodologies (5Why, DMAIC, 8D, C&E) in identifying, prioritizing, communicating, and resolving quality issues - NC & CAPA.
- Evaluating Quality data to identify process improvement opportunities within the supply chain.
- Support on Internal (Site) & External (Supplier) Engineering Change Management & participate in as required in CFT in conjunction with key stakeholders
- Coordinate Change Management & Control with Suppliers and implement changes at Supplier.
- Promote the use of continuous improvement methodologies such as Lean, Six Sigma, Poka- Yoke (Error Proofing), Measurement System Analysis (MSA), Statistical process control (SPC) and Process Failure Mode and Effects Analysis (pFMEA)
What you will need:Required Qualifications:
B.Tech in Electronics, Electrical, or Mechanical Engineering.
4–8 years of experience in Quality Engineering, Manufacturing Engineering, or a related quality function — preferably in the medical device or regulated industry.
Demonstrated CAPA ownership experience: root cause analysis, corrective action planning, effectiveness verification, and closure documentation.
Hands-on experience with PPAP, control plans, and inspection methods in a manufacturing environment.
Proficiency in problem-solving tools: 5-Why, 8D, DMAIC, FMEA, and Cause & Effect (Ishikawa) analysis.
Working knowledge of Power BI (dashboard creation and data visualization) and Advanced MS Excel (data analysis, pivot tables, automation).
ISO 13485 awareness or auditor certification is an advantage.
Experience with Trackwise enterprise QMS or equivalent quality management platform is an advantage.
Experience working in a Global Capability Center (GCC) environment or supporting global/cross-regional stakeholders.
Working knowledge of advanced quality tools: Six Sigma (Green Belt or Black Belt preferred), SPC, FMEA, Control Plans, Poka-Yoke, Kaizen, and Lean Manufacturing.
Strong commodity domain knowledge — understands technology, regulatory requirements, and supplier technical capabilities relevant to the product scope.
Experience training or coaching suppliers in quality tools and processes.
Exposure to AI-enabled quality tools or digital quality platforms is an advantage.
Skills Required
- B.Tech in Electronics, Electrical, or Mechanical Engineering
- 4-8 years experience in Quality Engineering, Manufacturing Engineering, or related quality function (preferably medical device or regulated industry)
- Demonstrated CAPA ownership: root cause analysis, corrective action planning, effectiveness verification, closure documentation
- Hands-on experience with PPAP, control plans, and inspection methods in manufacturing
- Proficiency in problem-solving tools: 5-Why, 8D, DMAIC, FMEA, Cause & Effect (Ishikawa)
- Working knowledge of Power BI (dashboard creation and visualization) and advanced Microsoft Excel (pivot tables, data analysis, automation)
- ISO 13485 awareness or auditor certification
- Experience with TrackWise enterprise QMS or equivalent quality management platform
- Experience supporting global/cross-regional stakeholders or working in a Global Capability Center (GCC)
- Six Sigma certification (Green Belt or Black Belt preferred); experience with SPC, FMEA, Control Plans, Kaizen, Lean, Poka-Yoke
- Strong commodity domain knowledge and supplier coaching/training experience
- Exposure to AI-enabled quality tools or digital quality platforms
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.
