Supplier Development Quality Engineer Ii Jobs in Los Angeles, California

Bachelors Degree (± 16 years) Related field. OR an equivalent combination of education and work experience

Education And Experience You’ll Bring

Trains inspectors to these procedures.

Develops and/or sources inspection tools and equipment.

Assists in generating component specifications.

Dispositions and drives corrective action as necessary.

5+ years of experience in supplier development, procurement, or a related field, with a focus on electro-mechanical commodities

Strong technical knowledge of manufacturing processes and cost drivers for electro-mechanical commodities

Experience in working with cross-functional teams to drive cost reduction and process improvement initiatives

Excellent communication, negotiation, and analytical skills

California only full-time salary range between $104,000-180,000 (senior - senior staff) + equity + benefits.

Bachelor's degree in engineering, supply chain, or a related field

Experience in IATF16949 type requirements, APQP, PPAP, DFMEA, PFMEA required.

Facilitate communication, clarification of technical requirements, and Design for Manufacturing (DFM) between Suppliers and Purchasing, Quality, and Design teams.

Conduct supplier audits to ensure their capabilities to meet part performance, delivery, and reliability expectations during supplier selection.

5+ years of experience developing and launching complex assembly processes.

Experience with Geometric Dimensioning & Tolerancing (GD&T) and a broad variety of measurement and inspection techniques.

Automotive or agricultural manufacturing experience is a plus.

Lead Auditor certification (ISO 13485, CFR 820 or comparable industry standard and regulatory requirements).

Lean Six Sigma green certification, or overall sound knowledge of lean tools with the ability to apply lean principles.

Bachelor's Degree in a Science, engineering, or related discipline, or equivalent years of experience.

Minimum 5 years' experience in quality, engineering, manufacturing, and/or procurement, or equivalent experience.

Working knowledge of FMEA, validation, and SPC processes.

You will also serve as a liaison between and a critical supplier. Key responsibilities include.

Good documentation, communication, and interpersonal relationship skills including negotiating and relationship management skills

Experience withmedical device compliant investigations (CAPA's, NCR's, Root-Cause Analysis)

Experience inmedical devices(cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment preferred.

Experience in complaint investigations,root cause analysis, and the associated risk assessments preferred.

Previous experience working with lab/industrial equipment required

Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering

Proficient in project management, analytical, critical thinking, problem solving and prioritization skills

Establish new initiatives to support ongoing improvement of Supplier Quality Management Systems

Robust understanding of QSR, Design Control, ISO, Product Risk Management and GMPs as defined in CFR 820

Excellent people interaction, team building, leadership, and communication skills including providing effective presentations.

Demonstrate innovative and implementation skills

Demonstrate knowledge of Statistics and Data Analysis to drive data based results and decisions

Defines product qualification strategy in alignment with D&E and Manufacturing Engineering

Arranges and control supplier interface processes, such as issue resolution, root cause analysis, qualification, deviation, ASML factory disturbances.

Can learn and apply new information or skills.

Quality, to secure the level of industrialization required to manufacture this part with zero defects in high volume.

Secures (NPI) first time right into the ASML factory or customers.

Defines the complex parts list with Technology Gaps enabling supplier selection with sourcing.

Shockwave Medical offers a competitive total compensation package as well as the following benefits and perks -

BS degree in a related engineering discipline with 0-2 years of relevant experience or a Master’s Degree

Effective communication skills (verbal, written, presentation)

Knowledge of Quality Systems (eg: cGMP, FDA 820 QSR, ISO 13485) is a plus

Knowledge of statistics, Six Sigma, Lean is a plus

Exact compensation may vary based on skills, expertise, and location

Familiarity with quality management and planning tools

Advanced experience with MS Excel. Minitab preferred

US Employees may be eligible for the following benefits:

Health Care and Dependent Care Flexible Spending Accounts

Business Travel Accident and Business Travel Health

Flexible Time Off, Paid Holidays

Defines product qualification strategy in alignment with D&E and Manufacturing Engineering

Arranges and control supplier interface processes, such as issue resolution, root cause analysis, qualification, deviation, ASML factory disturbances.

Quality Certifications are a plus.

Can learn and apply new information or skills.

Quality, to secure the level of industrialization required to manufacture this part with zero defects in high volume.

Secures (NPI) first time right into the ASML factory or customers.

Bachelor degree in Engineering with at least 3 years of experience or an equivalent combination of education and work experience

Knowledge of Quality System Mfg Process

General Knowledge of industry practices, techniques, and standards

Knowledge of Quality and Traceability Systems (MESS/SAP/eCAPA/Windchill)

General knowledge of quality metrics

Responsible for the final Process Monitor Release for products prior to distribution.

Support Quality Management in maintaining and updating the company’s Quality Program.

Knowledge of manufacturing processes, machining, welding, shop tools, equipment, and health/safety requirements.

Great interpersonal and communication (both written and verbal) skills.

Excellent organizational and negotiation skills.

Knowledge of industry standards as they relate to valves.

Experience in reading engineering drawings.

Interface between internal departments and on site supplier development and management.

Foster and maintain strong relationships with key suppliers as an extension of the primary points of contact.

Perform on-site audits and evaluations to ensure suppliers meet the company's quality and performance standards.

Implement continuous improvement initiatives to enhance the overall quality of supplied components.

Collaborate on design for manufacturability (DFM) initiatives to enhance component manufacturability and assembly.

Proactively identify potential issues or bottlenecks in the supply chain and manufacturing processes.

Experience in project management, manufacturing floor, fast-paced medical device operations environment and component supplier manufacturing process.

Demonstrated understanding of QSR and ISO standard (ISO 9001, ISO 13485) requirements for Material/Purchasing Controls, Validation and CAPA.

Experience with materials/components specifications and manufacturing processes.

Experience with Laboratory Equipment: Measuring Tools and Failure Analysis.

Experience with inspection methods for components i.e., analytical, or dimensional test methods.

Experience with problem solving quality tools.

Experience in process validation, design controls, risk management, and CAPA.

Experience with quality systems and processes, and project management.

Project management: ability to influence cross functional global teams spanning quality, operations, R&D, and sourcing.

BS degree in engineering or related technical field with minimum of 3-5 years of relevant experience.

Experience with medical device suppliers

Experience as lead auditor of quality systems (ISO13485 or similar)

Strong knowledge of test data management to reuse automated test data provisioning capabilities

Working experience with GitHub, Jenkins for the source code management

Effectively engineers and leverages tools and Engineering practices (DevOps tools and processes, source code management, Service Virtualization, monitoring tools, etc.)

Ensures respective programs/ policies/practices are well managed, meets business needs, complies with internal and external requirements, and aligns with business priorities

Actively manages relationships within and across various business lines, corporate and/or control functions and ensures alignment with enterprise and/or regulatory requirements

Maintains a culture of risk management and control, supported by effective processes in alignment with risk appetite

Interface with Project Management, Operational Excellence, and Digital Solutions to support part qualification approvals.

Streamlining qualification of components and assemblies from Suppliers to Customers, involving:

Creating/modifying the current excel workbooks to create a mistake proof template and ensure clear and uniform communication of requirements.

Create guidance material on the completion of First Article Submissions, PPAPs, and Process Qualifications.

Develop a method of tracking the status of qualification packages.

Support preparation of First Article Submissions, PPAPs, and Process Qualifications, testing the above method.

Primary POC for; Internal review meetings, Project Management Reviews, and liaison with Suppliers QA teams supporting current and future contracts

Use quality improvement tools such as 8D, Six-Sigma, Kaizen and metric management and reporting.

Work with Supply Chain, Quality Control, Engineering, and Program Management to ensure incoming material meets product specifications.

Experience in interpreting contract conditions covering quality requirements and quality planning

Support program, product development, and engineering groups covering key QA requirements.

Represent QA team with internal and external customers regarding QA requirements and outputs in formal and informal settings.

BS degree in Mechanical or Electrical Engineering with 0 - 2 years related experience.

Experience with quality systems, quality processes, internal auditing, or ISO13485

Experience with manufacturing support or process development

Experience with medical device suppliers

Monitors supplier performance to drive improvement and corrective action in the quality of components sourced from outside suppliers.

Develops and maintains incoming acceptance methods for materials and trains incoming inspectors to procedures.

ASQ, ISO13485, CSQP or other relevant supplier management related certifications

Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy.

Effective problem solving, root-cause analytical skills to lead and influence others to drive change (cross-functionally and globally)

Ability to manage complex projects ensuring all required deliverables are executed on time and in a compliant manner

Experience working within medical device industry

Working knowledge of Lean methodology or Six Sigma principles

Provide support for QMS (Quality Management System)

Oversee Document Control as well as product life cycle management.

$80,000 - $110,000 per year (based on experience)

Experience with CAPAs, Supplier Quality, Internal/External Audits, NPRs, Document Control, eQMS.

Assistance with audits - both internal and external

Collaborate with other departments in order to address quality issues and facilitate CAPA procedures.

Verified leadership and business skills and a reputation for making timely and sound decisions

Robust interpersonal, organizational, problem-solving, and analytical skills

Developing and mentoring suppliers in delivery and quality improvements

Auditing the delivery process and creating action plans to achieve 100% on-time delivery

Ensuring the resolution of Supplier quality issues escalated from the Quality department

Conducting supplier quality audits of current and potential suppliers

Assess supplier performance through analytical analysis and communicate findings to management.

Your Primary Responsibilities Will Include

Review and help manage supplier-related quality concerns and customer returns.

Thorough knowledge of APQP, PFMEA, and DFMEA processes.

Excellent analysis and critical thinking skills.

Excellent verbal and written communication skills.

Strong project management skills and ability to support suppliers through the assessment/qualification process

Manage supplier non-conformances Supplier Change Request (SCR) activities

Experienced with Geometric dimensioning and tolerancing for mechanical parts, as well as electrical and PCBA specification conventions

Experience with mechanical and electronic component specifications and quality assurance

Supplier Quality Experience in PCBAs, PCBA components, electronics, or electrical components

Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems

IATF 16949 certification requirements knowledge required.

AIAG Core tools knowledge and application experience are required.

Ensure compliance with all IATF 16949 requirements and particularly those that are customer specific

Ensure supplier quality-related deliverables are achieved on time (including PPAP requirements)

At least five years of automotive industry manufacturing experience is required.

Six Sigma BB certification (or equivalent) desired.

Understanding of project management(experience preferred)

Aide Manufacturing in the evaluation and qualification of new supplier materials following a defined new product development process

Other duties as assigned by the Manager

Strong written and verbal communication skills

Advanced computer skills using Microsoft Office applications

Knowledge of various quality system methodologies 8D, Lean, 5 Why’s, Pareto Analysis, Six Sigma, 8-D, DFMEA, PFEMA, PPAP, etc. preferred

Requirements (knowledge, Skills & Abilities)

Will adhere to all quality requirements that are inside of the Quality Management system.

EDUCATION AND EXPERIENCE (required Levels)

Maintaining constant communication with supplier to ensure all quality requirements are being meet. Example: Heat Cert, DoC, packaging standard.

Coordinate with Supply Chain (local and/or global) & Engineer on new component supplier qualifications and any new supplier approval.

Manage the New Supplier approval process according to the QMS.

Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.

Spine & Biologics, offers procedural solutions for spine surgery, and bone grafting solutions for spinal fusion. 

US and International travel requirement: Less than 10%

China Cranial, Spinal, Orthopedics & Technologies, provides solutions in spine surgery, neurosurgery, surgical synergies, biologics, and orthopedics.

Define and maintain statistical thresholds for complaint monitoring. Execute post market trending process.

Collaborate with cross-site Post Market Quality, Regulatory Affairs, and Engineering to support and author pre- and post-market product risk assessments.