QA Engineer

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

This role is a Fixed Term- Maternity Cover

In this fully onsite role, the QA Engineer supports product developments and provides quality oversight to the R&D activities while working within a multi-functional team environment for medical devices.

The QA Engineer will play an active role to ensure the design and development process meets quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and applicable regulatory requirements as well as being involved in QA activities.

Essential Duties And Responsibilities

• QA focal point for R&D 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 R&D and lab documentation- reviewing and approving technical and DHF documentation and lab work instructions/test method.
• Responsible for approval of product development DHF documentation (DDP, PRD, TMX, design verification & validation activities, dFMEA risk documents, test methods, protocols, reports, product design transfer)
• Responsible for approval of product design changes and process changes (ECO)
• Finding solutions for queries within responsibility limits
• Assist and provide guidance on any out of specification result, deviation, or excursion that may occur
• QA representative in product development design 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
• Responsible for approval of labelling
  
  

Education

• B.Sc. in Science or Engineering required
  
  

Work Experience

• Minimum 2 years of experience in Medical Device / Pharma industry required
• Experience with Medical Device Design & Development, Verification Activities, Risk Management, Product Transfer, DHF Activities preferred
• Strong working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971 preferred
  
  

Preferred Knowledge, Skills And Abilities

• Ability to work under pressure
• Good interpersonal skills
• Technical skills
• Creativity
• Quick learner
• Orderly and organized person
• The ability to prioritize based on importance
• Written and verbal expression skills: Hebrew- Excellent, English- Excellent
• Relevant work history and/or experience may be considered in lieu of degree
  
  

Travel Requirements

None: No travel required

Physical Requirements

Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

Additional Requirements

• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events
• Maintain the ability to work well with others in a variety of situations
• Maintain high attention to detail, accuracy, and overall quality of work
• Be able to multi-task, work under time constraints, problem solve, and prioritize
  
  

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.