Supplier Quality Engineer II
2 days ago
The Supplier Quality Engineer II will play a critical role in driving quality initiatives within the Transcatheter Mitral & Tricuspid Therapies (TMTT) business unit. This cross-functional position involves collaborating with multiple departments, including R&D, Design Assurance, Operations, Regulatory Affairs, Supplier Development Engineering, and Receiving Inspection. The primary responsibility is leading part qualification efforts with external suppliers to meet product development and commercial launch timelines. The role is fast-paced and dynamic, requiring proactive problem-solving and initiative.
How You Will Make an Impact:
• Facilitate and perform gage studies, process capability studies, and supplier process validations related to critical component features based on FMEA risk assessments.
• Develop and validate test methods, including creating inspection routines on optical measurement equipment and designing inspection fixtures using SolidWorks.
• Create test method procedures and provide training to team members.
• Provide engineering support to Receiving Inspection on component test methods and investigations.
• Support component specification development, identify critical features, develop inspection methods and plans, validate test methods, and conduct component capability assessments.
• Contribute to risk management activities, including FMEA development, process control plans, and quality agreements with 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.
• Oversee supplier corrective action requests, from initiation to closure.
• Collect and analyze quality metrics related to Supplier Quality.
• Communicate supplier quality risks during Management Review and project meetings, and provide solutions to mitigate risks.
• Support process and system improvement projects as assigned by the manager.
What You'll Need (Required Qualifications):
• Bachelor's degree in engineering or a scientific field with at least 2 years of experience in supplier quality, quality, manufacturing, R&D, or production engineering activities; OR a Master's degree in engineering or a scientific field with no experience (or relevant internship/co-op experience).
• Experience in highly regulated industries.
• Ability to travel up to 25%.
What Else We Look For (Preferred Qualifications):
• Engineering degree.
• Experience in the Medical Device, Aerospace, or Automotive industries.
• Knowledge of FDA's 21 CFR Part 820, ISO 13485, ISO 9001, and other international regulatory standards.
• Experience in Design Controls and test method development/validation.
• Proficiency in statistical techniques such as Gage R&R, Statistical Process Control, and Process Capability Studies.
• Strong root cause analysis skills and ability to drive non-conformance investigations, corrective actions, and CAPA assessments.
• Knowledge of GD&T and ability to read and interpret engineering drawings.
• Understanding of process validations (IQ, OQ, PQ).
• Familiarity with manufacturing processes (e.g., injection molding, extrusion, machining).
• Strong interpersonal skills with the ability to influence and negotiate.
• Ability to multi-task while maintaining attention to detail.
• Ability to achieve results in a cross-functional team environment and build strong relationships with internal and external customers (suppliers).
Education: Bachelors Degree
-
Supplier Quality Engineer II
3 days ago
Irvine, United States Compunnel Full timeJob Summary: The Supplier Quality Engineer II will play a critical role in driving quality initiatives within the Transcatheter Mitral & Tricuspid Therapies (TMTT) business unit. This cross-functional position involves collaborating with multiple departments, including R&D, Design Assurance, Operations, Regulatory Affairs, Supplier Development Engineering,...
-
Irvine, United States Edwards Lifesciences Full timePlease note that this is an "onsite" role, and the successful candidate will be expected to work from our corporate Irvine, CA campus.** Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest...
-
Irvine, United States Edwards Lifesciences Full timePlease note this is an onsite role, and the successful candidate will be expected to work from our corporate Irvine, CA campus.** Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of...
-
Quality Engineer II
3 weeks ago
Irvine, United States Planet Pharma Full timeQuality Engineer II Location: Irvine, CA Contract Duration: 6 months Target Pay Rate: $42/hr. with flexibilityAbout the TeamOur group focuses on New Product Development (NPD) quality and design assurance for medical devices, particularly in the area of transcatheter heart valve replacement (TAVR). This is a transformative area of healthcare, offering...
-
Quality Management Systems Engineer
3 weeks ago
Irvine, United States SysMind Tech Full timeRole name: Engineer Role Description: Quality Management Systems, FDA, Presentation, Strong communication skills, ISO 13485, Medical Device, Regulatory Standards, Quality Compliance, CAPA / NC Competencies: EIS : Medical Device & Regulations Experience (Years): 6-8 Essential Skills: A minimum of Technical/Engineering Degree with 8+ years of related...
-
Quality Assurance Engineer
6 days ago
Irvine, California, United States SysMind Tech Full timeAt SysMind Tech, we are seeking a Quality Assurance Engineer to join our team. As a key member of our organization, you will play a critical role in ensuring the quality of our products and services.The estimated salary for this position is $120,000 - $150,000 per year, depending on experience.The Job Description:Provide timely business support for the...
-
Quality Assurance Engineer
2 hours ago
Irvine, California, United States Edwards Lifesciences Full timeJob OverviewAs a Senior Supplier Quality Engineer at Edwards Lifesciences, you will play a critical role in ensuring the quality and integrity of our medical device components. We are seeking an experienced professional to lead successful part qualification efforts with external suppliers, supporting product development and commercial launch timelines.
-
Engineer II, R&D
5 days ago
Irvine, United States Edwards Lifesciences Full timeInnovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease. As part of our R&D Engineering team, you will work closely with our Quality and Manufacturing teams to develop the latest...
-
Senior Quality Assurance Engineer
22 hours ago
Irvine, California, United States SysMind Tech Full timeJob Overview SysMind Tech is seeking a highly experienced Senior Quality Assurance Engineer to lead our Supplier Quality Management (SQM) function globally. The ideal candidate will have a minimum of 8+ years of related experience in the Medical Device domain, with expertise in regulatory compliance requirements, quality system regulations, and ISO...
-
Senior Quality Assurance Engineer
24 hours ago
Irvine, California, United States B. Braun Medical Inc Full timeOverviewB. Braun Medical Inc., a leading manufacturer of innovative medical products, is seeking a highly skilled QA Engineer II to join our team in Irvine, CA.This role offers an exciting opportunity to provide quality engineering support to production, ensuring compliance with company policies and procedures. The ideal candidate will have 4-6 years of...
-
Electrical Test Engineer II
3 weeks ago
Irvine, United States Astrix Full timeWe have an exciting 2-year contract opportunity for an Electrical Test Engineer II with a global industry leader dedicated to helping people see brilliantly. This is your chance to join the world’s largest medical device company, recognized for its cutting-edge advancements in Surgical and Vision Care.Job Title: Electrical Test Engineer IIContract Length:...
-
Quality Engineer III
23 hours ago
Irvine, California, United States B. Braun Medical Inc Full timeWe are looking for an experienced Quality Engineer IIIResponsibilities:• Establishes quality standards for products and processes and suggests modifications meant to prevent defects in components or final products.• Works closely with cross-functional teams, including product design, product management, and production, to identify and mitigate quality...
-
Quality Assurance Engineer
6 days ago
Irvine, California, United States Trinus Full timeJob OverviewWe are seeking a skilled Supplier Quality Management Specialist to join our team at Trinus Corporation. This is an exciting opportunity to work with a leading provider of technology solutions and services, where you will be responsible for ensuring the quality of our suppliers.
-
Engineer II
3 weeks ago
Irvine, United States TalentMovers Full timeWork Location: 9650 Jeronimo Road, Irvine CA USA 92618 Description: REQ NOTES: 100% On-site 5 days a week (Mon-Fri - flexible hours) *The questions that are unanswered in the wizard will be asked during the Supplier Spotlight call PRIMARY FUNCTION: Eaton Aerospace in Irvine, CA has an opening for a Senior Post Development Support (PDS) Engineer. The PDS...
-
Mechanical Engineer II
1 week ago
Irvine, California, United States AnDek Staffing Services Full timeJob OverviewWe are seeking a highly skilled Mechanical Engineer II to join our team at AnDek Staffing Services.The estimated salary for this position is $80,000 - $110,000 per year, depending on experience and location.About the RoleThis is a full-time position with opportunities for growth and professional development.You will be responsible for carrying...
-
Senior Quality Engineer
5 months ago
Irvine, United States ShiftCode Analytics Full timeTitle: Senior Quality Engineer (Design) Location: Irvine, CA On-site Duration: 6 months+ Visa: Any Visas(except h1b and CPT) Interview: Phone/Zoom Key Role Responsibilities: • Focus on activities supporting design control, design verification/validation, FMEA/risk management, specification development, statistical reliability, critical to...
-
Quality Control Specialist II
4 days ago
Irvine, California, United States US Tech Solutions Full time**Job Title:** Quality Control Specialist II**Estimated Salary:** $110,000 - $140,000 per annumAbout the Role:We are seeking a highly skilled and experienced Quality Control Specialist II to join our team at US Tech Solutions. As a Quality Control Specialist II, you will be responsible for ensuring compliance with all regulatory requirements, including cGMP,...
-
PM - Quality Engineer I
3 weeks ago
Irvine, United States First Tek Full timeDevelops, modifies, applies, and maintains quality standards and evaluation methods for products and processes. Provides moderately complex statistical information for quality improvement by determining and applying testing methods and criteria. Coordinates and guides technical evaluations, analysis, and related data acquisition processes to ensure division...
-
Research and Development Engineer II
2 weeks ago
Irvine, United States Compunnel Inc Full timeJob Summary: This Engineer II will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and systems/procedures to optimize product design, internal and external device manufacturing, and device distribution. Furthermore, this Quality Engineer will coordinate and perform complaint investigations as...
-
Engineering - Engr II, R&D CA
3 weeks ago
irvine, United States TalentBurst Full timeJob Title: Quality Engineer II Duration: 6 Months Contract Location: Irvine, CA Job Description: This Quality Engineer II will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and systems/procedures to optimize product design, internal and external device manufacturing, and device distribution....