Senior Quality Engineer R&D

Company: West Pharmaceutical Services, Inc
Location: Scottsdale
Posted on: April 5, 2021

Job 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 $1.84B in 2019. 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 Sr. Quality Engineer is accountable for supporting new product development and provides quality oversight to the Research & Development (R&D) organization while working within a multi-functional team environment for medical devices. The Quality Engineer will handle projects and tasks, from product inception through design transfer and play an active role to ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and other regulatory requirements. The Quality Engineer will also execute transactions in relevant GMP systems (MasterControl, SAP, Share Point) and other relevant quality functions as applicable including site audit support. Essential Duties and Responsibilities:

• Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards
• Supports technical and design review activities as a Quality representative SME
• Review and approval of qualification documentation and reports
• Assist and provide guidance on any nonconformance that may occur
• Work cross-functionally with individuals and project or extended teams to ensure success of projects
• Attend program meetings as required as part of extended program teams
• Liaison with company and customers on Quality matters
• Provide Quality oversight of qualification/validation/design controls activities
• Other duties as assigned Basic Qualifications:
  • Bachelor Degree in Engineering or Science required
  • Minimum 5 years of experience in Quality (preferably Medical Devices)
  • Experience with customer interface and meeting customer expectations
  • Experience with Project Management, Quality Risk Management
  • Familiar with regulatory guidance such as ISO 13485, 21 CFR 820.30 Preferred Knowledge, Skills and Abilities:
    • Previous experience with MasterControl, SAP, Share Point, Teamcenter
    • Excellent written and verbal communication skills, including facilitation and presentation skills
    • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
    • Support and contribute in 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.
      Travel Requirements:
      • Must be able to travel up to 10% of the time Physical & Mental Requirements:
        • Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
        • Maintain high attention to detail, accuracy, and overall quality of work.
        • Effectively communicate and interface with various levels internally and with customers.
        • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description 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 disability or special need that requires accommodation, please send an email to peggy.tayloe@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.

Keywords: West Pharmaceutical Services, Inc, Scottsdale , Senior Quality Engineer R&D, Engineering , Scottsdale, Arizona