Loading...
 
Share this Job
Apply now »

Title:  QA Engineer

Requisition ID:  42542
Date:  Nov 24, 2021
Location: 

Ra'anana, Central district, IL

Department:  Quality
Description: 

 

 

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

 

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

 

Job Summary:

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

the QA Engineer, R&D 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:

 

  1. QA focal point for R&D projects in design and development processes.
  2. Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards
  3. Responsible for final approval of R&D documentation- reviewing and approving technical and DHF documentation.
  4. 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)
  5. Responsible for approval of product design changes
  6. Finding solutions for queries within responsibility limits
  7. Assist and provide guidance on any out of specification result, deviation, or excursion that may occur
  8. QA representative in product development design reviews
  9. Work cross-functionally with individuals and project or extended teams to provide guidance and ensure success of projects
  10. Attend program meetings as required as part of extended program teams
  11. provide support, when necessary with review and approval of equipment qualification (URS, pFMEA risk documents, IQ, OQ, PQ), process validation, process and equipment changes
  12. Support other QA dept activities- second approval of batch release/graphics, routine sterility validation maintenance activities, calibration etc.
     

Basic Qualifications: 

  • Education: B.Sc. in Science or Engineering
  • Minimum 2 years of experience in Medical Device Quality & Product Development Lifecycle
  • Experience in Medical Device / Pharma industry
  • Experience with Medical Device Design & Development, Verification Activities, Risk Management, Product Transfer, DHF Activities
  • 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, 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

Travel Requirements:

  • N/A

Competencies/Authorities

  1. Approve product development documents (DDP, PRD, TMX, design verification & validation activities, dFMEA risk documents, test methods, protocols, reports, product design transfer)
  2. Approve of process/equipment/product changes
  3. Approve equipment qualification documents (URS, pFMEA risk documents, IQ, OQ, PQ)
  4. Approve validation protocols and reports

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 Apply.Accommodation@westpharma.com.  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.

Apply now »