Senior Quality Supplier Engineer / Quality Supplier Manager Job at ASML (Kulim, Penang)

Supplier Quality Senior Engineer

This is where you make a difference in our patients’ safety. As a member of the ...

Location

Costa Rica , Cartago

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree or equivalent experience in Materials, Industrial, Chemical, Production, Systems, Electrical, Electronic, Electromechanical Engineering, or a related field
Sophisticated English proficiency (written and verbal)
Minimum 5 years of validated experience in Quality Systems within regulated industries, preferably medical devices or pharmaceuticals
Strong experience in Supplier Quality Management and external supplier oversight
Validated knowledge of: Regulatory standards (ISO 13485, FDA QSR, GMP)
Quality tools (risk management, problem source investigation, CAPA)
Knowledge and experience in Project Management
Leadership skills with the ability to work multi-functionally and balance priorities successfully

Job Responsibility

Lead, review, approve, and supervise the execution of Change Control activities concerning vendors, including evaluation of vendor change notifications
Develop, review, and improve procedures related to the management of supplier quality, including supplier qualification, supplier monitoring, and supplier requalification processes
Plan, coordinate, and participate in supplier audits (onsite or remote), including follow‑up of audit findings and verification of efficiency
Lead Supplier Corrective and Preventive Actions (SCARs), ensuring timely resolution and balanced root cause analysis
Monitor, analyze, and trend supplier performance metrics (quality, delivery, cost, and compliance)
Actively support investigations of non‑conforming material, deviations, manufacturing exceptions, and market complaints with a supplier component
Collaborate with teams from multiple functions in: New supplier qualification
Technology transfer projects
New product introductions
Validation and periodic review activities involving suppliers

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Supplier Quality Senior Engineer

As a Supplier Quality Senior Engineer, the role involves developing, planning, a...

Location

Costa Rica , Cartago

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree or equivalent experience in Materials, Industrial, Chemical, Production, Systems, Electrical, Electronic, Electromechanical Engineering, or a related field
Sophisticated English proficiency (written and verbal)
Minimum 5 years of validated experience in Quality Systems within regulated industries, preferably medical devices or pharmaceuticals
Strong experience in Supplier Quality Management and external supplier oversight
Validated knowledge of: Regulatory standards (ISO 13485, FDA QSR, GMP)
Quality tools (risk management, problem source investigation, CAPA)
Knowledge and experience in Project Management
Leadership skills with the ability to work multi-functionally and balance priorities successfully

Job Responsibility

Lead, review, approve, and supervise the execution of Change Control activities concerning vendors, including evaluation of vendor change notifications
Develop, review, and improve procedures related to the management of supplier quality, including supplier qualification, supplier monitoring, and supplier requalification processes
Plan, coordinate, and participate in supplier audits (onsite or remote), including follow‑up of audit findings and verification of efficiency
Lead Supplier Corrective and Preventive Actions (SCARs), ensuring timely resolution and balanced root cause analysis
Monitor, analyze, and trend supplier performance metrics (quality, delivery, cost, and compliance)
Actively support investigations of non‑conforming material, deviations, manufacturing exceptions, and market complaints with a supplier component
Collaborate with teams from multiple functions in: New supplier qualification
Technology transfer projects
New product introductions
Validation and periodic review activities involving suppliers

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Supplier Quality Senior Engineer

This is where you make a difference in our patients’ safety. As a member of the ...

Location

Costa Rica , Cartago

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree or equivalent experience in Materials, Industrial, Chemical, Production, Systems, Electrical, Electronic, Electromechanical Engineering, or a related field
Sophisticated English proficiency (written and verbal)
Minimum 5 years of validated experience in Quality Systems within regulated industries, preferably medical devices or pharmaceuticals
Strong experience in Supplier Quality Management and external supplier oversight
Validated knowledge of: Regulatory standards (ISO 13485, FDA QSR, GMP)
Quality tools (risk management, problem source investigation, CAPA)
Knowledge and experience in Project Management
Leadership skills with the ability to work multi-functionally and balance priorities successfully

Job Responsibility

Lead, review, approve, and supervise the execution of Change Control activities concerning vendors, including evaluation of vendor change notifications
Develop, review, and improve procedures related to the management of supplier quality, including supplier qualification, supplier monitoring, and supplier requalification processes
Plan, coordinate, and participate in supplier audits (onsite or remote), including follow‑up of audit findings and verification of efficiency
Lead Supplier Corrective and Preventive Actions (SCARs), ensuring timely resolution and balanced root cause analysis
Monitor, analyze, and trend supplier performance metrics (quality, delivery, cost, and compliance)
Actively support investigations of non‑conforming material, deviations, manufacturing exceptions, and market complaints with a supplier component
Collaborate with teams from multiple functions in: New supplier qualification
Technology transfer projects
New product introductions
Validation and periodic review activities involving suppliers

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Senior Supplier Quality Engineer

As a global medtech company, we are driven by our Vision of changing the traject...

Location

United States , Clear Lake

Salary:

110000.00 - 120000.00 USD / Year

LivaNova

Expiration Date

Until further notice

Requirements

A Bachelor's Degree in Engineering is required
8+ Years of Quality or Manufacturing Engineering
Experience working in a regulated environment industry such as a FDA medical device manufacturer preferred
Understanding of basic quality engineering principles including, but not limited to: quality leadership, implementation, acceptance sampling, statistical process control, lean business systems and other continuous improvement techniques, and risk management
Pragmatic and result-oriented: capable to prioritize and plan activities with specific attention to understand expectations of internal personnel and external stakeholders
Good team player: open and honest when communicating among peers and management
Resolves most issues with peers, but understands what issues are important to escalate to management
Project management skills including the ability to drive cross-functional internal and external teams to completion of projects within planned timeframes
Strong interpersonal skills
Sustained record of performance during tenure in previous position as shown through consistency with which metrics in their areas of responsibility meet performance objectives as established in Management Review and a track record of implementing improvements

Job Responsibility

Leads the supplier selection, evaluation and approval process by assessing manufacturing/ technology capabilities, supplier risk levels, Quality Management System compliance, etc.
Serves as a core team member on component development teams by providing technical leadership and direction
Responsible for supplier process qualification, verification and validation activities
Reviews supplier process changes for completeness, accuracy, and safety/effectiveness including the identification of all impacts and timely management of these changes with to ensure continued supply of parts
Acts as business process owner for all supplier related nonconformance report (NCR) management system, including material review board (MRB) activities, monitoring the timeliness and effectiveness of the system and activities
Carries out supplier Quality Management System (QMS) and process audits
Collaborates with suppliers on process manufacturing process improvement, process validation (TMV, IQ, OQ and PQ) and value enhancement opportunities
Ensures ongoing compliance per ISO 13485 and MDSAP requirements
Collaborates with Purchasing and procurement functions to support business strategy initiatives including cost saving efforts, alternate sourcing, outsourced processes etc.
Provides quality criteria (risk assessment, acceptance criteria, sample size, parameter definition) for receiving inspection activities

What we offer

Health benefits – Medical, Dental, Vision
Personal and Vacation Time
Retirement & Savings Plan (401K)
Employee Stock Purchase Plan
Training & Education Assistance
Bonus Referral Program
Service Awards
Employee Recognition Program
Flexible Work Schedules
discretionary annual bonus

Fulltime

Senior Supplier Quality Engineer

Location

Poland , Rzeszow

Salary:

Not provided

BorgWarner

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Engineering (preferred fields: Mechanical Engineering, Mechatronics, Materials Engineering, Production Engineering)
5–7 years of experience in Supplier Quality or Engineering within the automotive industry
Strong ability to read and interpret technical drawings, with advanced knowledge of GD&T
Hands-on experience leading PPAP and APQP processes, with full understanding of the qualification lifecycle
Knowledge of automotive standards: IATF 16949, AIAG, VDA (VDA 6.3 qualification is a strong advantage)
Experience in conducting process and system audits (VDA 6.3 auditor qualification is an asset)
Good understanding of manufacturing technologies: machining, powder metallurgy, stamping, and heat treatment
Practical knowledge of quality tools and methodologies: 8D, 5 Why, Root Cause Analysis, FMEA, FTA
Proficiency in MS Office
SAP knowledge is an advantage

Job Responsibility

Conduct comprehensive supplier evaluations and identify risks within the supply chain
Perform supplier visits and audits (process, system, and product audits, including VDA 6.3)
Oversee implementation and effectiveness of corrective and preventive actions at supplier sites
Analyze the quality performance of supplied components and make decisions regarding quality status and incoming inspection requirements
Issue supplier claims, manage escalations, and ensure timely closure of corrective actions
Monitor supplier quality KPIs, initiate improvement actions, and drive supplier development to achieve quality targets
Approve parts for serial production within the PPAP process, with full responsibility for acceptance/rejection decisions
Lead APQP activities to ensure quality objectives are achieved in new projects
Conduct root cause analysis using methodologies such as 8D and 5 Why
Represent the SQE function during internal and external meetings, escalations, and technical reviews

Fulltime

Senior Supplier Quality Engineer

The Interventional Urology Sr. Supplier Quality Engineer will support our ongoin...

Location

United States , Minneapolis

Salary:

115876.00 - 173813.00 USD / Year

Coloplast

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant science or engineering discipline
5+ year of related experience in supplier management
2+ years of experience in medical device manufacturing
Experience in medical device process and product validation, sampling, and statistics (e.g. DOE, process analysis/capability, Minitab, and repeatability and reproducibility) highly preferred
Able to travel up to 10%
Knowledge of FDA regulations (21 CFR Part 820) and ISO standards (13485, 14971) and their application
Ability to apply standard techniques, procedures, and criteria to perform assigned tasks
Exercises judgment on details of work and able to demonstrate knowledge and developing skills in the supplier quality function
Analytical problem-solving skills
Experience with continuous improvement, Lean six-sigma, or similar programs and techniques

Job Responsibility

Provide direct quality engineering support and strategic solutions to the supply chain to ensure quality compliance, FDA/ISO compliance and issue resolution
act as the supplier quality subject matter expert (SME) in appropriate projects
Manage the Supplier Quality Audit program
includes performing audits or coordinating an outside firm to perform the audits, maintain the Supplier Quality Audit schedule and audit-related records/documents
Act as internal interface/liaison and partner to Corporate Procurement
Active participation in Material Review Board meetings
Initiate and update Supplier Quality Agreements
Recommend and implement quality improvements of product and processes to promote continuous improvement at suppliers and contract manufacturers
Initiate supplier investigation requests and assist in root cause investigations for supplier related issues
Participate in product and process risk management activities

What we offer

Comprehensive medical, dental, and vision insurance plans
Access to company sponsored wellness programs and mental health resources
Paid leave of absence for qualifying events
Generous paid parental leave for both birthing and non-birthing parents
Competitive 401(k) plan with company match that vest immediately
Financial planning services
Corporate discount programs for goods and services
Generous paid time off
Flexible work hours
Flexible work arrangement options

Senior Supplier Quality Engineer

The Senior Supplier Quality Engineer position implements and maintains the suppl...

Location

United States , Burnsville

Salary:

100000.00 - 130000.00 USD / Year

Imricor Medical Systems

Expiration Date

Until further notice

Requirements

Bachelor of Science in engineering, science, or related technical field
5+ years of Engineering and/or Quality experience
Experience with Microsoft Office: Word, Excel, PowerPoint
Knowledge of basic Quality Systems and good documentation practices
Knowledge of FDA, GMP, and ISO regulations

Job Responsibility

Implements and maintains the supplier management program
Works with both development and manufacturing to provide technical support in the identification, selection, and qualification of suppliers and components
Responsible for monitoring and managing supplier performance throughout the product development cycle
Monitor supplier performance and drive improvement and corrective action in the quality of components sourced from outside suppliers
Is the primary role that works with Imricor suppliers to perform supplier selection and qualification, component qualification, supplier monitoring, and supplier corrective actions
Drives supplier selection and qualification activities by interfacing with external suppliers to generate and review supplier surveys, quality agreements, nondisclosure agreements, and other supplier qualification documentation
Conducts supplier quality management system audits both virtually and in-person
Is responsible for successful completion of component qualification activities including review and development of purchased product specifications, collaboration with suppliers, determination of component qualification deliverables and acceptance criteria, and analysis of results
Develops receiving inspection plans and associated test method development activities
Monitors, analyzes, and identifies trends from supplier quality and performance data

What we offer

Medical
Dental
Vision
Health Savings Accounts
Health Care & Dependent Care Flexible Spending Accounts
Disability Benefits
Life Insurance
Retirement Benefits

Fulltime

Senior Supplier Quality Engineer

Seeking a Supplier Quality Engineer.

Location

United States , Irvine

Salary:

50.00 - 70.00 USD / Hour

Apex Systems

Expiration Date

Until further notice

Requirements

A minimum of a Bachelor's or equivalent University degree
a concentration in Engineering or related scientific field is preferred
A minimum of four (4) years of relevant work experience
Experience leading and owning investigations, NCs, CAPAs or deliverables
Critical thinking skills
Excellent written and verbal communication skills with attention to detail
Hands on production line experience
Medical device experience

Job Responsibility

Support with end-to-end External Manufacturing and Supplier Quality activities, including but not limited to: process validations, manufacturing site transfers, NC/CAPA root cause investigations, Change Control, Supplier Quality Agreement updates, Approved Supplier List (ASL) updates, metric analysis and reporting, process improvements
Provide sound, risk-based QA direction and independent and timely decision-making on a wide range of quality and compliance issues
Ensure compliant execution of Quality Management Systems
Provide leadership across activities associated with supplier risk identification & management
Exercise strong communication and interpersonal skills, with the ability to work independently and in a team environment, to effectively support supplier relationship
Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements under limited supervision
Adaptable and flexible for other duties that may be assigned as needed

What we offer

Medical, dental, vision, life, disability, and other insurance plans
ESPP (employee stock purchase program)
401K program with company match after 12 months
HSA (Health Savings Account on the HDHP plan)
SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions
Corporate discount savings program
On-demand training program
Access to certification prep and a library of technical and leadership courses/books/seminars after 6+ months
Certification discounts

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Senior Quality Supplier Engineer / Quality Supplier Manager

Job Description

Job Responsibility

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