Supplier Quality Engineer Ii

2+ years

Not Disclosed

Irvine

10 Jan. 18, 2025

Job Description

Job Type: Full Time Education: B.E./BCS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Supplier Quality Engineer II
Location: Irvine, CA 92614
Employment Type: Contract
Job Category: Engineering
Job Number: 616620
Is Job Remote?: No
Country: United States

Job Overview

Planet Pharma is seeking a Supplier Quality Engineer II to join the Transcatheter Mitral & Tricuspid Therapies (TMTT) business unit. This cross-functional role involves collaborating with R&D, Design Assurance, Operations, Regulatory Affairs, Supplier Development Engineering, and Receiving Inspection teams. The primary focus is on leading part qualification efforts with external suppliers to meet product development and commercial launch timelines.

Key Responsibilities

Facilitate and perform gage studies, process capability studies, and supplier process validations related to critical components.
Develop and validate test methods, create inspection routines, and design inspection fixtures using SolidWorks.
Create and provide training on test method procedures.
Support component specification development, identification of critical features, and process validation activities.
Contribute to risk management activities, including FMEAs, process control plans, and quality agreements at suppliers.
Use statistical techniques and six sigma tools to analyze processes and drive continuous improvement.
Conduct on-site supplier audits and manage supplier-related non-conformances.
Manage supplier corrective action requests (from initiation to closure).
Collect and analyze Supplier Quality metrics, communicating risks to management.
Support process and system improvement projects.

Required Qualifications

Bachelor’s degree in engineering or a scientific field with at least 2 years of relevant experience, or Master’s degree with no experience (or internship/co-op experience).
Experience in a highly regulated industry.
Ability to travel up to 25%.

Preferred Qualifications

Engineering degree.
Experience in the Medical Device, Aerospace, or Automotive industries.
Knowledge of FDA’s 21 CFR Part 820, ISO13485, ISO9001, and other regulatory standards.
Proficiency in statistical techniques (e.g., Gage R&R, Statistical Process Control, Process Capability Studies).
Experience in Design Controls and test method development/validations.
Knowledge of GD&T and manufacturing processes (e.g., injection molding, extrusion, machining).
Strong interpersonal and negotiation skills.

Additional Information

Planet Pharma is an equal opportunity employer committed to diversity, equity, and inclusion.

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Supplier Quality Engineer Ii

Job Description

Job Overview

Key Responsibilities

Required Qualifications

Preferred Qualifications

Additional Information

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