Manufacturing Quality Engineer

Requisition ID: 65934
Date: May 21, 2024
Location:

Shlomi, Northern district, IL

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 role, the Manufacturing Quality Engineer will own all activities at one of the subcontractors (West Israel's production processes are carried out by subcontractors), supports the validation process, and provides 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 the 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 products and production focal point for our sub-contractors and will be responsible for projects related to the production and machines, including training, audits, stop and renew the production.

Essential Duties and Responsibilities:

General
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.
Documentation
Responsible to write, review and approve pilot documents (including reports).
write and approve various department and production procedures and forms.
Production
Lead investigation processes for deviations and nonconformities in production and create analysis reports.
Responsible to train 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 relates 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.

Basic Qualifications:

B.Sc. in Engineering or Science required.
Minimum 3 years of experience in Quality Engineering positions preferably in Medical Device & Production lifecycle.
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 is an advantage.
Working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971, MDSAP- Advantage
Must have very good interpersonal skills.
Ability to work independently, multi-task and thrive in fast-paced environment.
Problem solving including root cause failure analysis methods.

Preferred Knowledge, languages, Skills and Abilities:

Graduate degree in Engineering
Previous experience with MasterControl, Share Point, SAP, 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
Effectively communicate and interface with various levels internally and with customers
Certified auditor- a plus

Travel Requirements:

None

Physical & Mental Requirements:

Very Heavy/ Heavy/ Medium/ Light/ Sedentary: Sedentary
List any mental requirements: communication, quick decision making, interpreting data, reading or writing, must be able to express or exchange ideas with employees, must be able to understand direction and adhere to established procedures.

Delegation/s (Title): Senior Engineer Quality Manufacturing TL

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to [email protected]. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.