Senior Quality Engineer R&D
Company: West Pharmaceutical Services
Location: scottsdale
Posted on: May 3, 2021
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Job Description:
Scottsdale Arizona 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 * Strong project management skills * 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, Scottsdale , Senior Quality Engineer R&D, Other , scottsdale, Arizona
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