QA Engineer

Requisition ID: 65496
Date: Apr 18, 2024
Location:

Ra'anana, Central 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, you will be supporting Engineering and R&D departments as well as being involved in QA activities.

The QA engineer position is temporary for 2 years (project support).

Essential Duties and Responsibilities:

QA focal point for engineering projects in design and development processes.
Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations, and standards.
Responsible for final approval of engineering documentation- reviewing and approving technical, mold and process validation documentation (IQ, OQ, PQ).
Assist and provide guidance on any out of specification result, deviation, or excursion that may occur
QA representative in equipment and process validation reviews
Work cross-functionally with individuals and project or extended teams to provide guidance and ensure success of projects.
Attend program meetings as required as part of extended program teams.
Provide support, when necessary, with review and approval of product development DHF documentation (DDP, PRD, TMX, design verification & validation activities, dFMEA risk documents, test methods, OOSs, protocols, reports, product design transfer)
Support other QA dept activities- second approval of batch release/graphics, routine sterility validation maintenance activities (dose audit and bioburden), calibration etc.
Responsible for final approval of engineering documentation- reviewing and approving test method validation

Competencies/Authorities

Approve equipment qualification documents (URS, pFMEA risk documents, IQ, OQ, PQ)
Approve validation protocols and reports.
Support all engineering activities.

Basic Qualifications:

Education: B.Sc. in Science or Engineering or any other relevant education
Experience in Medical Device / Pharma industry minimum 2 years of experience
Experience with Medical Device Design & Development, Verification Activities, Risk Management, Product Transfer, DHF Activities – advantage
Experience in Equipment Validation, Process Validation, Change Control Process
Strong working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971

Preferred Knowledge, languages, Skills and Abilities:

Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
Support and contribute to Lean Sigma programs and activities towards delivery of the set target
Able to comply with the company’s safety policy at all times
Able to comply with the company’s quality policy at all times.
Technical skills
Written and verbal expression skills: Hebrew- Excellent, English- Excellent
Relevant work history and/or experience may be considered in lieu of degree.

Travel Requirements:

Must be able to travel up to 10% of the time.

Physical & Mental Requirements:

Very Heavy/ Heavy/ Medium/ Light/ Sedentary:
List any mental requirements:
Ability to work under pressure.
Good interpersonal skills
Creativity
Quick learner
Orderly and organized person
The ability to prioritize based on importance.

Delegation/s (Title):

Qualified QA

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.