Ensuring compliance to Supplier management activities identified by organization.
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 to facilitate root cause analysis and corrective actions of supplier quality issues.
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)
Evaluate Quality data to identify process improvement opportunities within the supply chain.
Coordinate Change Management & Control with Suppliers and implement changes at Supplier.
Review of process and equipment Validation including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Special Process Validations, and Test Method Validations.
Inspecting and testing materials, equipment, processes, and products to ensure quality specifications are met.
Prioritizing, reviewing, and delivering First Article Inspections FAIs for sustaining parts and development projects.
What you will need:Required Qualification:
B.Tech (Electronics/Electrical/Mechanical) with 2-5 years of experience in Quality / Engineering / Manufacturing environment.
Quality Processes/ Tools - Working knowledge of basic and advanced Quality tools such as; PPAP, Six Sigma, SPC, FMEA, Control Plans, Root Cause Analysis, Poke Yoke, Kaizen, Lean Manufacturing etc.
Executes/implements/ improve all supplier quality tools/ Processes. Trains supplier in these tools effectively.
Proficient in MS Office Suite (including Word, Excel, Power Point etc).
Strong interpersonal skills to work with cross-functional teams (engineering, R&D, manufacturing, regulatory affairs).
Understanding of Medical Device Regulatory Compliance (ISO 13485, CFR 820, or comparable standard / regulation) and EU's Medical Device Directive.
Excellent communication and influencing skills, with the ability to manage multiple tasks and represent the Quality function across teams
Preferred ASQ Certified Quality Engineer (CQE).
Commodity Domain Knowledge – Strong Knowledge & understands technology, regulatory requirement related to product, system & services.
Travel Percentage: 10%
Skills Required
- B.Tech (Electronics/Electrical/Mechanical) with 2-5 years in Quality/Engineering/Manufacturing
- Working knowledge of quality tools: PPAP, Six Sigma, SPC, FMEA, Control Plans, Root Cause Analysis, Poka-Yoke, Kaizen, Lean Manufacturing
- Experience with PPAP associated with new product launches and management of production cycles/manufacturing transfers
- Execute, implement, and improve supplier quality tools/processes and train suppliers
- Proficient in MS Office Suite (Word, Excel, PowerPoint)
- Strong interpersonal skills to work with cross-functional teams (engineering, R&D, manufacturing, regulatory affairs)
- Understanding of medical device regulatory compliance (ISO 13485, CFR 820, EU MDD)
- Excellent communication and influencing skills; ability to manage multiple tasks and represent Quality across teams
- ASQ Certified Quality Engineer (CQE)
- Commodity domain knowledge: technology and regulatory requirements related to product, system and services
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.
