Quality Engineer - Validation Job at Nemera (Buffalo Grove)

Quality Engineer - Validation

The Quality Validation Engineer is responsible for planning, coordinating and ma...

Location

United States , Buffalo Grove, Illinois

Salary:

85000.00 - 105000.00 USD / Year

Nemera

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Science or related field
3+ years' of experience in a Quality position strongly preferred
Experience in the Medical Device industry strongly preferred (ISO13485)
Experience with technical writing, IQ/OQ/PQ is preferred
Experience with equipment validation is preferred
Experience working onsite in Manufacturing is strongly preferred
Excellent communication skills with the ability to understand, read, write and speak English required
Must have the ability to apply advanced mathematical concepts and intermediate statistical (SPC) knowledge
Six-sigma experience, training or certification preferred
Intermediate level computer skills, including Microsoft Office applications required

Job Responsibility

Assists the Quality Manager in coordinating and executing objectives throughout the company
Identify and coordinate resolution of system inefficiencies
Coordinate and manage the execution of validations and creation of written protocols
Coordinate and manage the execution of change control activities
Assess results of Customer Complaint investigations and Corrective Actions
Utilize CAPA problem solving techniques
Develop and analyze statistical data
Evaluate compliance using relevant information and individual judgment
Develop product specifications for existing products
Plan, coordinate, and manage assigned Supplier Quality evaluations

Fulltime

Sr Quality Engineer, Validation

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

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

To prepare, execute, compile and review protocols of equipment, utility, process validation, cleaning validation, and facility qualification
To coordinate with cross functional teams of all departments for execution of all validation activities & inform to Manager regarding any non-conformity from planning and execution
To prepare monthly and annual calendars for various periodic qualification/validations & get it reviewed by Manager and approved by Manager
To monitor the QMS elements like Change Control Management, Corrective and Preventive Action, OOS, non-conformance related to the validation activity and prepare investigation report and ensure proper closure of the QMS documents in Track wise
To review the scheduled validation activity as per calendar and send it to the cross functional & PPA department in advance for execution planning before the scheduled date
To ensure samples withdrawal during process validation & keep Manager updated about any non-conformity
To ensure compilation of executed protocols is done online (as applicable) and observation sheets for process validation and other qualifications are duly filled & signed. To ensure the CFS closure of respective documents
To co-ordinate with projects and other cross functional dept. for prior information on new equipment installation and to prepare the protocol in advance, followed by new equipment qualification and get it reviewed by the Manager
To attend training of each protocol before execution of any validation and qualification activity
To collect data & compile summary report for submission to International Regulatory Affairs (IRA) for queries and ANDA

Job Responsibility

Prepare, execute, compile and review protocols of equipment, utility, process validation, cleaning validation, and facility qualification
Coordinate with cross functional teams of all departments for execution of all validation activities
Prepare monthly and annual calendars for various periodic qualification/validations
Monitor QMS elements related to validation activity and ensure proper closure of QMS documents
Review scheduled validation activity as per calendar
Ensure samples withdrawal during process validation
Ensure compilation of executed protocols and observation sheets
Coordinate with projects for new equipment installation and prepare protocol
Attend training of each protocol before execution
Collect data & compile summary report for submission to International Regulatory Affairs (IRA)

What we offer

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

Fulltime

Sr Quality Engineer, Validation

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

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

To prepare, execute, compile and review protocols of equipment, utility, process validation, cleaning validation, and facility qualification
To coordinate with cross functional teams of all departments for execution of all validation activities & inform to Manager regarding any non-conformity from planning and execution
To prepare monthly and annual calendars for various periodic qualification/validations & get it reviewed by Manager and approved by Manager
To monitor the QMS elements like Change Control Management, Corrective and Preventive Action, OOS, non-conformance related to the validation activity and prepare investigation report and ensure proper closure of the QMS documents in Track wise
To review the scheduled validation activity as per calendar and send it to the cross functional & PPA department in advance for execution planning before the scheduled date
To ensure samples withdrawal during process validation & keep Manager updated about any non-conformity
To ensure compilation of executed protocols is done online (as applicable) and observation sheets for process validation and other qualifications are duly filled & signed
To ensure the CFS closure of respective documents
To co-ordinate with projects and other cross functional dept. for prior information on new equipment installation and to prepare the protocol in advance, followed by new equipment qualification and get it reviewed by the Manager
To attend training of each protocol before execution of any validation and qualification activity

Job Responsibility

To prepare, execute, compile and review protocols of equipment, utility, process validation, cleaning validation, and facility qualification
To coordinate with cross functional teams of all departments for execution of all validation activities & inform to Manager regarding any non-conformity from planning and execution
To prepare monthly and annual calendars for various periodic qualification/validations & get it reviewed by Manager and approved by Manager
To monitor the QMS elements like Change Control Management, Corrective and Preventive Action, OOS, non-conformance related to the validation activity and prepare investigation report and ensure proper closure of the QMS documents in Track wise
To review the scheduled validation activity as per calendar and send it to the cross functional & PPA department in advance for execution planning before the scheduled date
To ensure samples withdrawal during process validation & keep Manager updated about any non-conformity
To ensure compilation of executed protocols is done online (as applicable) and observation sheets for process validation and other qualifications are duly filled & signed
To ensure the CFS closure of respective documents
To co-ordinate with projects and other cross functional dept. for prior information on new equipment installation and to prepare the protocol in advance, followed by new equipment qualification and get it reviewed by the Manager
To attend training of each protocol before execution of any validation and qualification activity

What we offer

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

Fulltime

Sr Quality Engineer, Validation

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

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

To prepare, execute, compile and review protocols of equipment, utility, process validation, cleaning validation, and facility qualification.
To coordinate with cross functional teams of all departments for execution of all validation activities & inform to Manager regarding any non-conformity from planning and execution.
To prepare monthly and annual calendars for various periodic qualification/validations & get it reviewed by Manager and approved by Manager.
To monitor the QMS elements like Change Control Management, Corrective and Preventive Action, OOS, non-conformance related to the validation activity and prepare investigation report and ensure proper closure of the QMS documents in Track wise.
To review the scheduled validation activity as per calendar and send it to the cross functional & PPA department in advance for execution planning before the scheduled date.
To ensure samples withdrawal during process validation & keep Manager updated about any non-conformity.
To ensure compilation of executed protocols is done online (as applicable) and observation sheets for process validation and other qualifications are duly filled & signed. To ensure the CFS closure of respective documents.
To co-ordinate with projects and other cross functional dept. for prior information on new equipment installation and to prepare the protocol in advance, followed by new equipment qualification and get it reviewed by the Manager.
To attend training of each protocol before execution of any validation and qualification activity.
To collect data & compile summary report for submission to International Regulatory Affairs (IRA) for queries and ANDA.

Job Responsibility

To prepare, execute, compile and review protocols of equipment, utility, process validation, cleaning validation, and facility qualification.
To coordinate with cross functional teams of all departments for execution of all validation activities & inform to Manager regarding any non-conformity from planning and execution.
To prepare monthly and annual calendars for various periodic qualification/validations & get it reviewed by Manager and approved by Manager.
To monitor the QMS elements like Change Control Management, Corrective and Preventive Action, OOS, non-conformance related to the validation activity and prepare investigation report and ensure proper closure of the QMS documents in Track wise.
To review the scheduled validation activity as per calendar and send it to the cross functional & PPA department in advance for execution planning before the scheduled date.
To ensure samples withdrawal during process validation & keep Manager updated about any non-conformity.
To ensure compilation of executed protocols is done online (as applicable) and observation sheets for process validation and other qualifications are duly filled & signed. To ensure the CFS closure of respective documents.
To co-ordinate with projects and other cross functional dept. for prior information on new equipment installation and to prepare the protocol in advance, followed by new equipment qualification and get it reviewed by the Manager.
To attend training of each protocol before execution of any validation and qualification activity.
To collect data & compile summary report for submission to International Regulatory Affairs (IRA) for queries and ANDA.

What we offer

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

Fulltime

Quality Engineer (MES & Cleaning Validation)

Are you ready to make a tangible impact on global health? Join a world-class lea...

Location

Belgium , Geel

Salary:

Not provided

Randstad

Expiration Date

August 19, 2026

Requirements

Bachelor's degree or higher in life sciences, chemistry, biology, pharmacy, engineering, or information technology
Minimum of 3 years of experience in Chemical/Pharmaceutical Supply Chain or Quality Assurance
Strong understanding of manufacturing operations, production systems, and GMP environments
Experience with cleaning validation is required
Proficiency with the PAS-X Manufacturing Execution System (MES) is an asset
Familiarity with Delta-V systems is a plus
Professional proficiency in English

Job Responsibility

Review and approve Master Batch Records and technical recipes to ensure accurate and compliant commercial API production
Perform data extraction, abstract material reviews, and author, review, and approve relevant QA procedures
Deliver essential quality oversight for cleaning validation processes
Support small-scale optimization projects and daily tasks within the QA Commercial Operations team
Act as a strong, communicative partner, fostering collaboration between Business and Quality stakeholders

Fulltime

Software Test Engineer / Validation Engineer

To strengthen our testing and validation activities, we are looking for a Softwa...

Location

Italy , Modena

Salary:

Not provided

RE:LAB

Expiration Date

Until further notice

Requirements

Degree in Engineering (Electronics, Computer, Automation, or similar technical fields)
Experience in software testing, verification, and validation for complex systems
Familiarity with requirements-based testing and test case definition
Basic knowledge of electronics, embedded systems, or control units
Experience with test execution, defect analysis, and documentation
Ability to work in structured development and validation processes
Good command of the English language, both written and spoken

Job Responsibility

Contribute to the definition of test procedures and validation strategies for software and electronic systems
Analyze system and software requirements to support test planning and prevent defects early in the development process
Define and execute test cases at functional, integration, and system level
Support the analysis and resolution of software-related issues in collaboration with development teams and suppliers
Participate in verification and validation activities using test benches, simulation environments, or Hardware-in-the-Loop (HIL) setups
Contribute to test documentation, defect tracking, and validation reports
Collaborate with multidisciplinary teams involved in system development, testing, and quality activities

Fulltime

Lead Quality Assurance Engineer, Supplier Quality

The Lead Quality Assurance Engineer, Supplier Quality will provide supplier rela...

Location

United States , Madison

Salary:

112000.00 - 190000.00 USD / Year

Exact Sciences

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a Science or technical field
or Associate’s degree in Science or technical field and 2 years of relevant experience as outlined in the essential duties in lieu of a Bachelor’s degree
5+ years of experience in quality principles and practice including experience in assigned area (Design Control, Supplier Management, Risk Management, etc.)
Product Development assignments require 8+ years of experience in product development in the medical device industry with experience in complex systems including software
Design Transfer assignments require 8+ years of experience in process validation principles and practice
Manufacturing Support assignments require 8+ years of experience in a manufacturing operation environment
Demonstrated ability to successfully work within an CFR 820, ISO 13485, ISO 9001, and/or cGMP structured environment
Applicants must be currently authorized to work in country where work will be performed on a full or part-time basis
Demonstrated ability to perform the Essential Duties of the position with or without accommodation

Job Responsibility

Represent Quality on a variety of projects as assigned
Communicate and collaborate with business partners to ensure robust materials, products, processes, and systems and compliance to procedures and specifications
Create documentation and records in the Electronic Quality Management System (EQMS)
Perform risk assessments and provide risk mitigation strategies
Implement processes to monitor product and process performance, compliance, and reliability
Implement, conduct, and report on process quality programs using statistical data analysis
Review and approve documentation related to Exact Sciences products
Conduct periodic reviews of Quality System documentation
Generate and distribute Quality metrics as assigned
Generate, prepare, and issue data for assigned quality plans

What we offer

Paid time off (including days for vacation, holidays, volunteering, and personal time)
Paid leave for parents and caregivers
A retirement savings plan
Wellness support
Health benefits including medical, prescription drug, dental, and vision coverage
Bonus eligibility

Fulltime

Quality Assurance Quality Control Engineer

Location

Germany , Dresden

Salary:

Not provided

ASafe Global

Expiration Date

Until further notice

Requirements

Degree or diploma in Civil, Mechanical, Electrical Engineering or a related field
5+ years of relevant QA/QC experience, preferably in semiconductor, cleanroom, or high-tech industrial construction
Solid understanding of ISO standards, quality control processes, and construction QA/QC documentation
Strong experience with inspection test plans (ITPs), material verification, and construction methodology
Familiarity with EU and German quality standards and construction regulations
Excellent communication skills and ability to liaise with multidisciplinary teams
Fluent in English
Ability to work on-site in Dresden, Germany for the duration of the project
A valid Visa/Work permit for the specific job location is essential

Job Responsibility

Oversee and implement the quality control procedures for the construction project, ensuring compliance with all codes, standards, and client specifications
Conduct inspections, audits, and testing across all stages of construction activities
Review and approve material submittals, method statements, and test plans in coordination with engineering and project teams
Track and document all QA/QC activities and maintain inspection test records
Identify non-conformances, ensure timely corrective actions, and lead root cause analyses
Coordinate with subcontractors and vendors to verify quality compliance throughout the supply and installation phases
Participate in progress meetings and provide regular reporting on QA/QC metrics to the management team
Support project close-out through the preparation of handover documentation and as-built records

What we offer

Valuing Our Team: At ASafe Global, we recognize that our employees are our greatest asset, and we are dedicated to fostering a supportive and rewarding work environment
Competitive Compensation: We provide a competitive compensation package, ensuring that our employees are fairly rewarded for their contributions
Growth Opportunities: ASafe Global offers a range of professional development opportunities to support the continuous growth and advancement of our team members
Employee Success: We believe in the interconnectedness of our company’s success and the well-being of our employees, emphasizing a mutually beneficial relationship
Meaningful Impact: Play a key role in shaping the future of construction and innovation
Inclusive Workplace: Join a diverse and supportive team committed to forward-thinking solutions

Select Country

Quality Engineer - Validation

Job Description

Job Responsibility

Requirements

Nice to have

Looking for more opportunities?

Quality Engineer - Validation

Quality Engineer - Validation

Sr Quality Engineer, Validation

Sr Quality Engineer, Validation

Sr Quality Engineer, Validation

Quality Engineer (MES & Cleaning Validation)

Software Test Engineer / Validation Engineer

Lead Quality Assurance Engineer, Supplier Quality

Quality Assurance Quality Control Engineer

Our AI answers in your language