Manufacturing Quality Engineer

Requisition ID: 74881
Date: Jul 29, 2026
Location:

Shlomi, ISR, IL

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Department: Quality
Description:

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Job Summary

In this onsite role, the Manufacturing Quality Engineer will own on all activities at one of sub-contractors, support the validation process to the contract manufacturing and provide quality oversight to the engineering department, while working within a multi-functional team environment for medical devices. The Manufacturing Quality Engineer will lead projects and tasks, from product validation through transfer to production and play an active role to ensure products meet quality standards consistent with internal procedures and acceptance criteria. Additionally, this role will identify and implement improvements to the production processes. The Manufacturing Quality Engineer will be the product and production focal point for our sub-contractors and will be responsible for projects related to production and machines, including training, audits, stop and renewing the production.

Essential Duties and Responsibilities
Exhibit a strong “quality first” mentality and ensure that product and quality are held to the highest standard.
Meet company and departmental goals in the continuous improvement of all products, services and processes.
Work cross-functionally with individuals or extended teams to provide guidance and ensure success of projects.
Responsible to write, review and approve pilot documents (including reports).
write and approve various department and production procedures and forms.
Lead investigation processes for deviations and nonconformities in production and create analysis reports.
Responsible for training the sub-contractors according QA procedures and VoE.
Supports special processes such as sorting or rework in production.
Own on all production activities at one of the subcontractors to ensure manufacturing is held according to West procedures and GMP/GDP standards
Responsible for stopping and renewing production with accordance to West requirements and with MQ manager approval.
Manage production-related projects and act as MQ focal point in various internal and external projects- such as Data Integrity, CoPQ, production improvement plans, etc.
Provide Quality oversight of validation activities and processes.
Lead pilot processes which include change and approval of quality aspects in pilot protocols and reports and assure that pilot processes are conducted according to West guidance and protocols.
Attend production pilot meetings as the MQ focal point.
Essential Duties and Responsibilities:
Production
Lead investigation processes for deviations and nonconformities in production and create analysis reports.
Responsible for training the sub-contractors according QA procedures and VoE.
Supports special processes such as sorting or rework in production.
Own on all production activities at one of the subcontractors to ensure manufacturing is held according to West procedures and GMP/GDP standards
Responsible for stopping and renewing production with accordance to West requirements and with MQ manager approval.
Manage production-related projects and act as MQ focal point in various internal and external projects- such as Data Integrity, CoPQ, production improvement plans, etc.
Provide Quality oversight of validation activities and processes.
Lead pilot processes which include change and approval of quality aspects in pilot protocols and reports and assure that pilot processes are conducted according to West guidance and protocols.
Attend production pilot meetings as the MQ focal point.

Delegation
Manufacturing Quality Manager or qualified Manufacturing Quality
Team Lead Manufacturing Quality
Education
B.Sc. in Engineering or Science required
Work Experience
Minimum 3 years of experience in Medical Device Quality & Productionifecycle
Relevant work history and/or experience may be considered in lieu of degree
Experience with production processes and process controls
Experience with sub contractors interface and meeting customer expectations
Experience with Medical Device, Validation Activities, Risk Management, Product Transfer to production
Working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971, MDSAP
Preferred Knowledge, Skills and Abilities
Must have effective problem solving and interpersonal skills
Ability to work independently, multi-task and thrive in fast-paced environment
Problem solving including root cause failure analysis methods
Experience with Medical Device / Pharma- Advantage
Validation Activities, Risk Management, Product Transfer to production
Working knowledge of quality systems such as ISO 13485, 21 CFR 820,SO 14971, MDSAP
Physical Requirements
Light-Exerting up to 20lbs/9kg of force frequently, and/or negligible amount of force frequently constantly to move objects.
Additional Requirements
Previous experience with MasterControl, Share Point, Teamcenter- a plus
Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
Must maintain the ability to work well with others in a variety of situations
Maintain high attention to detail, accuracy, and overall quality of work
Must be able to multi-task, work under time constraints, problem solve, and prioritize
Observe and interpret situations, analyze and solve problems
Effectively communicate and interface with various levels internally and with customers
Certified auditor- a plus
Relevant work history and/or experience may be considered in lieu of degree

West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening.

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